What Is Elahere (mirvetuximab soravtansine)? FDA Approval, Turkish Authorization, and Reimbursement Status
In this article
What is Elahere? The first real breakthrough in ovarian cancer in twenty years—and now authorized in Türkiye
Platinum-resistant ovarian cancer was one of oncology's most discouraging areas. Chemotherapy options were used interchangeably, response rates remained in the 10-15% range, and none prolonged survival. In this setting, Elahere (mirvetuximab soravtansine) became the first drug shown to prolong overall survival in a randomized phase 3 trial . It received marketing authorization in Türkiye on July 31, 2026; as of September 2026, it is listed on the drug price list and can be prescribed. However, this drug comes with a side-effect profile that is unusual in oncology: its main toxicity affects the eyes, rather than blood counts. This article was prepared using the Turkish Summary of Product Characteristics (SmPC): it explains what the drug is, who can receive it, the numerical evidence of its effectiveness, and exactly what must be done to protect the eyes.
- What: A folate receptor alpha (FRα)-targeted antibody-drug conjugate (ADC). The IgG1 antibody carries an average of 3.4 DM4 molecules.
- Turkish authorization: 31.07.2026 · Authorization no. 2026/301 · Marketing authorization holder: AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Ltd. Şti. (Ataşehir/İstanbul).
- For whom: Adults with FRα-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 systemic therapies previously. It is not appropriate for patients with primary platinum-refractory disease.
- Evidence: MIRASOL phase 3 (N=453)—overall survival 16.46 months vs 12.75 months, HR 0.67 (p=0.0046). Response rate 42.3% vs 15.9%.
- Most important warning: At the beginning of the SmPC is a boxed warning: ocular toxicity. A baseline eye examination, a mandatory steroid eye-drop schedule, and a ban on contact lenses are required.
- Second major warning: Pneumonitis occurs in 10% of patients; in clinical trials, two patients died from respiratory failure (0.3%).
- Price: According to the drug price list, one vial costs 77,382.53 ₺ (list updated September 21, 2026); a typical cycle requires 4 vials.
- Access: The product's barcode is active (8680656080780), and it is sold with a restricted white prescription . It was not found on reimbursement lists—patients currently pay for it themselves.
- Nevertheless: the drug is less toxicthan the chemotherapy it was compared with. Severe side effects: 41.7% vs 54.1%; discontinuation due to side effects: 9.2% vs 15.9%.
- Product name: ELAHERE 5 mg/mL concentrate for solution for infusion (sterile, cytotoxic)
- Vial: 100 mg mirvetuximab soravtansine in 20 mL
- Date of first authorization: 31.07.2026 · Authorization number: 2026/301
- Marketing authorization holder: AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Limited Şirketi—Nidakule Ataşehir, İstanbul
- Product subject to additional monitoring: The SmPC displays an inverted black triangle. This means that the drug's safety profile is being closely monitored and suspected side effects are expected to be reported to TÜFAM .
What does antibody-drug conjugate mean?
Antibody-drug conjugate (ADC): A molecule consisting of three components—an antibody (the address finder), a linker (connecting component), and a cytotoxic payload (the actual cell-killing drug). The idea is to attach a molecule that would be too toxic to administer on its own to an antibody that binds to a protein carried only by tumor cells. The drug is administered into the bloodstream but acts mainly inside the target cell.
Elahere's structure: An anti-FRα IgG1 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary cells is attached via a cleavable linker to an average of 3.4 DM4 molecules. DM4 is an anti-tubulin agent in the maytansinoid class.
How it differs from chemotherapy: Chemotherapy attacks all rapidly dividing cells—hair follicles, bone marrow, and the intestine. With an ADC, damage shifts toward tissues containing the target protein. With Elahere, this shift is particularly clear: bone marrow suppression becomes less prominent, while the ocular surface takes center stage.
How does Elahere work? Five steps
- Binding to the target. The antibody component binds with high affinity to the folate receptor alpha (FRα) protein on the surface of the tumor cell. FRα is frequently overexpressed in ovarian cancer but is present only to a very limited extent in normal tissues—this is the basis of the drug's selectivity.
- Internalization. The bound complex is drawn into the cell as the cell membrane folds inward (endocytosis).
- Release of the payload. The complex reaches the lysosome, where the antibody is broken down into small peptides and its DM4 payload is released.
- Stopping cell division. DM4 inhibits the polymerization of tubulin, which forms the cellular skeleton. The cell cannot build the spindle structure needed for division, becomes arrested in the G2/M phase , and programmed cell death (apoptosis) is triggered.
- The bystander effect. Some DM4 may leak out of the cell and also attack nearby tumor cells that do not carry FRα (thebystander effect). This is an advantage when the tumor is heterogeneous, but also helps explain side effects in neighboring healthy tissues.
Figure 1 · The drug's journey inside the cell
Elahere is a delivery system, rather than simply a chemotherapy drug. The five steps below visually illustrate the list above.
The corneal epithelium is one of the body's most rapidly renewing tissues and is particularly sensitive to microtubule poisons. Combined with evidence that corneal epithelial cells carry folate receptors and the ability of ADCs to reach the ocular surface, this produces a common side-effect signature for this drug class. Ocular toxicity here is an anticipated problem managed through a protocol , rather than a surprise.
Who can receive it? Full wording of the Turkish indication
"For adults with folate receptor-alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, ELAHERE is indicated as monotherapy . It is not appropriate for use in patients with primary platinum-refractory disease."
This wording includes four separate requirements that are often omitted in Turkish-language sources. These are not arbitrary barriers; they define the patient population in which the drug has been shown to work. All must be met for treatment to fall within the indication.
| Requirement | What it means | How it is determined |
|---|---|---|
| 1. High-grade serous histology | Endometrioid, clear-cell, or mucinous subtypes are outside the indication | Pathology report |
| 2. Platinum resistance | Progression within 6 months after completion of platinum therapy | Treatment history and imaging schedule |
| 3. FRα positivity | 2+ and/or 3+ membrane staining in ≥75% of tumor cells | Immunohistochemistry using a validated test (preferably a CE-marked IVD) |
| 4. 1-3 prior systemic therapies | Excludes patients who have never received treatment or have received more than four lines | Treatment history |
| Also excluded: primary platinum-refractory disease | Patients who never responded to their first platinum therapy or progressed during treatment | Response to first-line treatment |
Platinum-resistant: The disease respondedto platinum but returned within 6 months of the last dose. Elahere is intended for this group.
Primary platinum-refractory: The disease never responded to the first platinum therapy or progressed while treatment was ongoing. The Turkish SmPC explicitly states that this drug is not appropriate for this group. This distinction is omitted in almost all Turkish-language sources and may lead to off-label use.
First-line treatment for ovarian cancer is platinum-containing chemotherapy (carboplatin or cisplatin). The disease is classified according to how soon it returns after this treatment:
Platinum-sensitive: Recurrence more than 6 months after the last platinum dose. Platinum can be tried again; the prognosis is relatively favorable.
Platinum-resistant: Recurrence within 6 months . Platinum no longer works; options become more limited. This is where Elahere fits.
Primary platinum-refractory: Progression during first-line platinum therapy or no response to that treatment. This group has the poorest prognosis, and the Turkish SmPC considers Elahere inappropriate for this subgroup . Note: the excluded group consists of patients who never responded to their first platinum therapy; patients who developed platinum resistance in later lines remain within the indication.
Figure 2 · Is the patient eligible for this drug? Four requirements and one exclusion
The indication in the Turkish SmPC consists of five successive checks. If any one is not met, use falls outside the indication.
FRα testing: a "positive" result is not enough; the threshold must be met
The Turkish SmPC defines patient selection as follows: eligible patients must meet the immunohistochemical criterion of ≥75% viable tumor cells showing moderate (2+) and/or strong (3+) membrane staining , assessed using an appropriate CE-marked in vitro diagnostic test ; if a CE-marked test is unavailable, a validated alternative test is used.
FRα staining in your tumor is not sufficient on its own. In the pathology report, both the extent (≥75% of cells) and intensity (2+ or 3+) of staining must meet this threshold. When you see "FRα positive," ask which criterion was used to define positivity. The first FDA-approved immunohistochemical test for this purpose in the United States is VENTANA FOLR1 (FOLR1-2.1) RxDx; the same test received CE marking on November 18, 2024 , becoming the first immunohistochemistry-based companion diagnostic test widely available in Europe.
The proportion of patients with platinum-resistant ovarian cancer who meet this threshold varies by method and histology. In a multicenter cohort using the same ≥75% / ≥2+ criterion, the rate was 50.7% (116/229), while another study using standardized criteria in high-grade serous carcinoma reported 43.5% . A cautious interpretation: roughly one-third to one-half of patients are eligible for this drug. The single figure of "35%" frequently repeated online does not have a single authoritative source.
FRα testing is not a formality; it is a prerequisite for the drug to work. In a tumor that does not carry FRα, there is no target for the antibody to bind to; the drug produces side effects without benefit. A recommendation for Elahere without testing should be questioned.
Marketing authorization does not mean the test is accessible—this is the real bottleneck for the drug in Türkiye. For this reason, we were informed of a statement that the marketing authorization holder would provide free FRα testing support in Türkiye. We could not verify this information through any publicly available source: no such program was found in the company's Turkish announcements or in any professional publication. We therefore do not describe its scope, application process, or duration.
We can confirm that similar programs have operated in other countries: in the United States, a company-sponsored free testing program called FR-ASSIST opened with the launch of Elahere and closed to new applications on December 15, 2024; FRα testing access programs run by laboratory companies also exist. Such support would therefore not be technically unexpected—but it is not currently verified for Türkiye. Ask your treating oncology clinic and pathology laboratory who will cover the cost of testing; if you are given the name of a program, have it confirmed in writing .
The indications in Türkiye, Europe, and the United States differ
| Türkiye (TİTCK) | Europe (EMA) | United States (FDA) | |
|---|---|---|---|
| Approval date | 31.07.2026 | November 18, 2024 | Accelerated: November 14, 2022 Full approval: March 22, 2024 |
| Histology requirement | High-grade serous | High-grade serous | None |
| Primary platinum-refractory disease | Not appropriate (explicitly stated) | Similar restriction | Not separately specified in the wording |
| Prior treatment | 1-3 systemic regimens | 1-3 systemic regimens | 1-3 systemic regimens |
| Mode of use | Monotherapy | Monotherapy | Monotherapy |
These differences are not technical details. An interpretation based on the United States labeling may imply off-label use in Türkiye. The applicable wording in Türkiye is the Summary of Product Characteristics approved by TİTCK , and it is narrower than the United States labeling.
The evidence: SORAYA opened the door; MIRASOL secured it
Elahere's approval story is a textbook example of how the accelerated approval system should work: conditional approval based on a small single-arm study, followed by confirmation in a randomized phase 3 trial. With many drugs, the second step is delayed or fails. That did not happen here.
FDA accelerated approval
Based on data from 106 patients in the phase 2 SORAYA study. Requirement: prior bevacizumab treatment. The FRα test was approved on the same day.
MIRASOL phase 3 resultsKey finding
In platinum-resistant ovarian cancer, the first randomized result showing prolonged overall survival. Publication: New England Journal of Medicine, 2023.
FDA full approval
The bevacizumab requirement was removed; the indication was expanded to 1-3 prior lines of therapy.
European Commission approval
An indication restricted to high-grade serous histology.
Phase 2 data in platinum-sensitive disease
In the 125-patient study presented at SGO 2026, the response rate was 62.4%. This indication is not yet approved.
Turkish authorizationNew
TİTCK authorization, no. 2026/301. The indication is aligned with Europe: it requires high-grade serous histology and states that use is not appropriate in primary platinum-refractory patients.
SORAYA (phase 2): the basis for accelerated approval
SORAYA was a single-arm study, meaning there was no comparison group. It enrolled 106 patients; all had previously received bevacizumab, half had received three lines of therapy, and almost half had used a PARP inhibitor. This was therefore a group whose options were genuinely exhausted.
| SORAYA (N=106) | Result |
|---|---|
| Objective response rate (ORR) | 32.4% (95% CI 23.6-42.2)—5 complete and 29 partial responses |
| Median duration of response (DOR) | 6.9 months (95% CI 5.6-9.7) |
| Median progression-free survival | 4.3 months (investigator assessment) |
| Median overall survival | 13.8 months (95% CI 12.0-not reached) |
Because SORAYA had no comparison arm, these results are insufficient to say "the drug prolongs survival." They only show that "this drug shrinks tumors." Oncology has many examples in which response rates did not translate into survival gains—which is why accelerated approvals are conditional and a confirmatory study is mandatory.
MIRASOL (phase 3): the key evidence
MIRASOL randomly assigned 453 patients to two arms: Elahere or the investigator's choice of single-agent chemotherapy (paclitaxel 40.7%, pegylated liposomal doxorubicin 35.8%, topotecan 23.5%). The drug was therefore tested against what patients actually receive in current practice , rather than against nothing.
| MIRASOL | Elahere (n=227) | Chemotherapy (n=226) | Comparison |
|---|---|---|---|
| Median progression-free survival | 5.62 months (4.34-5.95) |
3.98 months (2.86-4.47) |
HR 0.65 (0.52-0.81); p<0.0001 |
| Median overall survival | 16.46 months (14.46-24.57) |
12.75 months (10.91-14.36) |
HR 0.67 (0.50-0.89); p=0.0046 |
| Objective response rate | 42.3% (35.8-49.0) |
15.9% (11.4-21.4) |
p<0.001 |
| Complete response | 12 patients (5.3%) | 0 patients | — |
In the chemotherapy arm, no patient achieved a complete response; in the Elahere arm, tumors disappeared completely on imaging in 12 patients (5.3%). Median values describe a typical patient; the number of complete responses shows how deep an effect is possible in some patients . Both need to be considered together.
An unexpected finding: the more effective drug is also less toxic
The usual trade-off in oncology is greater efficacy with more severe side effects. MIRASOL broke that pattern.
Platinum-sensitive disease: not yet approved, but evidence is emerging
Elahere's approved use is limited to platinum-resistant disease. However, studies in platinum-sensitive disease are also ongoing:
- Phase 2 study presented at SGO 2026 (N=125): In FRα-positive, recurrent platinum-sensitive ovarian cancer, the confirmed response rate was 62.4% (62.7% in the FRα ≥50% subgroup); median duration of response was 11.2 months. The response rate remained 63.9% in patients previously treated with a PARP inhibitor. After induction, 81% of patients were progression-free.
- GLORIOSA phase 3 (NCT05445778): Maintenance mirvetuximab + bevacizumab versus bevacizumab alone. Target enrollment: 520 patients. The study is active but closed to recruitment; no results had been announced as of June 2026.
A 62% response rate is impressive, but it comes from a single-arm phase 2 study —just like SORAYA. Effective options already exist for platinum-sensitive disease (platinum rechallenge, PARP inhibitors, bevacizumab), and only randomized studies such as GLORIOSA can establish whether this drug is superior. Elahere use in platinum-sensitive disease is currently off-label.
How is it administered? Dose, preparation, and premedication
- Dose: 6 mg/kg— based on adjusted ideal body weight (AIBW) , rather than actual weight.
- Frequency: Intravenous infusion every 21 days, until disease progression or unacceptable toxicity.
- Dilution: Use only 5% glucose , to a concentration of 1-2 mg/mL. It is incompatible with 0.9% sodium chloride.
- Filter: Administration must use a 0.2 or 0.22 µm polyethersulfone (PES) in-line filter . No other membrane type should be used.
- Materials: DEHP-containing administration sets should be avoided. At the end of the infusion, the line is again flushed with 5% glucose.
- Prescribing physician: Treatment is initiated and supervised by a physician experienced in the use of anticancer medicines.
The dose is calculated using the patient's adjusted ideal body weight, rather than actual weight. The SmPC's rationale is clear: AIBW-based dosing reduces variability in drug exposure in underweight or overweight patients.
Formulas:
Female ideal body weight (IBW) = 0.9 × height(cm) − 92
AIBW = IBW + 0.4 × (actual weight − IBW)
The SmPC's own example —a female patient who is 165 cm tall and weighs 80 kg:
IBW = 0.9 × 165 − 92 = 56.5 kg
AIBW = 56.5 + 0.4 × (80 − 56.5) = 65.9 kg
Dose = 6 × 65.9 = 395 mg. Dosing by actual weight would give 480 mg—a difference of 21%.
Premedication: before every infusion, at least 30 minutes beforehand
| Group | Example drug and dose | Route | Timing |
|---|---|---|---|
| Corticosteroid | Dexamethasone 10 mg | Intravenous | At least 30 minutes before infusion |
| Antihistamine | Diphenhydramine 25-50 mg | Oral or intravenous | |
| Antipyretic | Paracetamol (acetaminophen) 325-650 mg | Oral or intravenous | |
| Antiemetic | 5-HT₃ serotonin receptor antagonist or an appropriate alternative | Oral or intravenous | Before every dose, after the other premedications |
The dose of dexamethasone used for premedication, its side effects, and problems with long-term use are explained in detail in our dexamethasone guide . In patients who previously experienced a grade 2 infusion reaction , additional premedication with dexamethasone 8 mg twice daily (or equivalent) should be considered on the day before administration.
Some Turkish-language sources state that "corticosteroids are not routine and are used only if a reaction occurs." This is incorrect. According to the SmPC, dexamethasone is part of standard premedication before every infusion. In addition, steroid eye drops are used on a scheduled basis during every cycle to protect the eyes.
Infusion rate
- Starting rate: 1 mg/minute. If well tolerated for 30 minutes → 3 mg/minute. If well tolerated for another 30 minutes → a maximum of 5 mg/minute.
- If there was no infusion reaction with the previous dose, subsequent infusions may begin at the highest tolerated rate.
- Storage: After the diluted solution is removed from the refrigerator, it must be administered within 8 hours (including infusion time). Do not freeze or shake.
Ocular toxicity: boxed warning and prevention protocol
"ELAHERE can cause serious ocular toxicity , including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis."
The warning contains four instructions: before treatment and regularly during the first 8 cycles, perform an ophthalmic examination ; administer prophylactic artificial tears and topical steroids ; in the event of toxicity, withhold treatment; discontinue treatment for grade 4 ocular toxicity.
Prevention protocol: three components
| What | When | How |
|---|---|---|
| Eye examination | Before treatment (baseline) → regularly during the first 8 cycles → subsequently as clinically indicated. For new or worsening symptoms, immediately. | Visual acuity + slit-lamp examination (biomicroscopy). Simply saying "my vision is fine" is insufficient; the cornea must be examined under a microscope. |
| Topical steroid eye drops | Every cycle: start 1 day before infusion | One drop in each eye 6 times daily through day 4; then one drop 4 times daily on days 5-8 of the cycle. Steroid prescriptions and renewals should be issued only after a slit-lamp examination . |
| Lubricating eye drops | Throughout treatment, at least 4 times daily and as needed | Administer at least 10 minutes after the steroid eye drops. |
Figure 3 · Eye protection schedule during a cycle
Eye protection is part of treatment. The schedule below shows a single 21-day cycle and is repeated every cycle.
The boxed warning and Section 4.2 of the Turkish SmPC describe eye examinations as "every other cycle during the first 8 cycles" , whereas Section 4.4 states "before every cycle during the first 8 cycles" . These statements conflict. The more frequent schedule is safer for the patient; in practice, examination frequency should be decided jointly by the treating team and the ophthalmologist . For any new or worsening symptom, both sections call for an immediate examination —there is no disagreement on this point.
- Do not wear contact lenses throughout treatment unless a healthcare professional advises otherwise.
- Keep the eye drops in the correct order —steroid first, wait at least 10 minutes, then artificial tears. Reversing the order dilutes the steroid's effect.
- Report new symptoms before every cycle. The SmPC lists the patient's responsibility to report new or worsening symptoms to the physician before each cycle as a separate instruction . For blurred vision, sensitivity to light, stinging, or pain, do not wait until the next appointment.
Dose modification tables
Dose levels: 6 mg/kg → 5 mg/kg → 4 mg/kg AIBW. If 4 mg/kg is also not tolerated, treatment is permanently discontinued. The 3-week interval between cycles is maintained. In a patient with new or worsening ocular symptoms, an ophthalmic examination is performed before dosing , and the physician makes a decision based on findings in the more severely affected eye .
| Adverse reaction | Grade / finding | Action |
|---|---|---|
| Keratitis / keratopathy | Nonconfluent superficial keratitis | Monitor; continue treatment |
| Confluent superficial keratitis, corneal epithelial defect, or loss of ≥3 lines of visual acuity | Until improvement, withhold treatment, then resume at the same dose. Consider a dose reduction in recurrent cases or for toxicity lasting longer than 14 days . | |
| Corneal ulcer, stromal opacity, or best-corrected vision of 6/60 or worse | Withhold treatment; reduce by one dose level | |
| Corneal perforation | Permanently discontinue | |
| Pneumonitis | Grade 1 | Monitor |
| Grade 2 | Withhold until grade ≤1, then resume at the next lower dose. If it recurs or lasts longer than 28 days , reduce the dose. | |
| Grade 3 or 4 | Permanently discontinue | |
| Peripheral neuropathy | Grade 2 | Withhold until grade ≤1; reduce by one dose level |
| Grade 3 or 4 | Permanently discontinue | |
| Infusion reaction / hypersensitivity | Grade 1 | Maintain the infusion rate |
| Grade 2 | Stop the infusion and provide supportive treatment; once symptoms resolve, resume at 50% of the previous rate , then gradually increase the rate if there are no problems | |
| Grade 3 or 4 | Discontinue the infusion; monitor the patient until infusion-related symptoms resolve | |
| Other adverse reactions | Grade 3 | Withhold until grade ≤1; reduce by one dose level |
| Grade 4 | Permanently discontinue |
Other side effects: how common and how severe?
The rates below come from pooled data on patients treated at 6 mg/kg AIBW across four clinical trials involving 682 patients (Turkish SmPC, Section 4.8). Median treatment duration was 19.1 weeks.
| Most common adverse reactions | Rate |
|---|---|
| Blurred vision | 43% |
| Nausea | 41% |
| Diarrhea | 39% |
| Fatigue | 35% |
| Abdominal pain | 30% |
| Keratopathy | 29% |
| Dry eye | 27% |
| Constipation | 26% |
| Vomiting | 23% |
| Decreased appetite | 22% |
| Peripheral neuropathy | 20% |
| Headache | 19% |
| Weakness (asthenia) | 18% |
| Increased AST | 16% |
| Joint pain (arthralgia) | 16% |
Very common other reactions (in at least one in 10 patients): urinary tract infection, anemia, thrombocytopenia, hypomagnesemia, photophobia, eye pain, pneumonitis, shortness of breath, cough, abdominal distension, increased ALT. Common reactions (1-10%): neutropenia, hypokalemia, dehydration, insomnia, taste disturbance, dizziness, hypertension, ascites, reflux, mouth sores, hyperbilirubinemia, itching, muscle pain, back pain, fever, infusion reaction.
The SmPC states that mirvetuximab soravtansine can cause severe, life-threatening, or fatal interstitial lung disease . Inflammation of lung tissue is considered a class effect of antibody-drug conjugates; how to recognize it and distinguish it from radiation pneumonitis is discussed in detail in our article on pulmonary side effects of ADCs .
The numbers: Pneumonitis occurred in 10% of patients; grade 3 in 0.9% (6/682), grade 4 in 0.2% (1/682). Two patients (0.3%) died from respiratory failure. The median time to onset was 18.1 weeks —usually after the fourth month of treatment.
What to monitor: Low oxygen levels, cough, shortness of breath, and interstitial infiltrates on imaging. Other causes, such as infection and tumor progression, must be excluded. New or worsening cough and shortness of breath should not be dismissed as "the cancer is progressing."
In clinical trials, it occurred in 36% of patients; 3% had grade 3 neuropathy. Median time to onset was 5.9 weeks. Symptoms include tingling, burning, numbness, neuropathic pain, muscle weakness, and altered sensation.
Neuropathy led to dose delays in 2%, dose reductions in 4%, and permanent treatment discontinuation in 0.7% of patients. Report difficulty with fine motor tasks such as fastening buttons or turning a key as soon as it begins —neuropathy recognized late may be permanent.
Which side effects interrupt treatment?
The SmPC lists the side effects most frequently leading to dose reduction or delay as follows: blurred vision 17%, keratopathy 10%, dry eye 5%, neutropenia 5%, keratitis 4%, cataract 3%, decreased visual acuity 3%, thrombocytopenia 3%, peripheral neuropathy 3%, pneumonia 3%. Five of the first six are ocular, showing why the eye protection protocol is critical to maintaining treatment.
In 12% of patients, side effects led to permanent treatment discontinuation. The most frequently reported serious adverse reactions were pneumonia 4%, small intestinal obstruction 3%, intestinal obstruction 3%, pleural effusion 2%, and abdominal pain 2%.
Who should not receive it, and what precautions are needed?
| Condition | What the SmPC says |
|---|---|
| Contraindication | Only hypersensitivity to the active substance or excipients |
| Mild hepatic impairment | No dose adjustment required |
| Moderate to severe hepatic impairment (total bilirubin >1.5×ULN) | Use should be avoided |
| Mild to moderate renal impairment (CLcr 30-90 mL/min) | No dose adjustment required |
| Severe renal impairment (CLcr 15-30 mL/min) / end-stage renal disease | Not evaluated; the need for dose adjustment is unknown |
| Age 65 or older | No dose adjustment required |
| Children | Use in this indication is not appropriate |
| Pregnancy | DM4 is genotoxic and may cause embryo-fetal harm |
| Contraception | Effective contraception during treatment and for 7 months after the last dose is required |
| Breastfeeding | Do not breastfeed during treatment or for 1 month after the last dose . |
A correction: Moderate to severe hepatic impairment is not a contraindicationfor this drug; it is a condition in which use "should be avoided." The only official contraindication is hypersensitivity. Some Turkish-language sources misrepresent this distinction.
Drug interactions
No clinical drug-drug interaction studies have been conducted. However, DM4 is a CYP3A4 substrate: concurrent use of strong CYP3A4 inhibitors may increase unconjugated DM4 levels and the risk of side effects. Tell your oncology team about all medicines you use—including antifungals, certain antibiotics, HIV medicines, and even foods such as grapefruit juice.
Pharmacokinetics and resistance
The situation in Türkiye: the drug can now be prescribed; reimbursement is the next question
Elahere received marketing authorization on July 31, 2026 from the Turkish Medicines and Medical Devices Agency (TİTCK). Authorization number: 2026/301; the marketing authorization holder is AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Limited Şirketi(Nidakule Ataşehir, İstanbul). The Turkish Summary of Product Characteristics and patient information leaflet have been published in TİTCK's SmPC/leaflet archive.
The product is subject to additional monitoring —as indicated by the inverted black triangle on the SmPC. This means its safety profile is being closely monitored and suspected side effects are expected to be reported to the Turkish Pharmacovigilance Center (TÜFAM) . Patients and physicians who notice a new side effect may submit a report.
Authorization, reimbursement, and access: three separate gates
Authorization is only the first step of a three-stage process. Confusing these stages is a frequent source of disappointment for patients and families.
| Stage | What it means | Who decides | Elahere's status |
|---|---|---|---|
| 1. Authorization | Approval of the quality, efficacy, and safety dossier allowing the drug to be sold in Türkiye | TİTCK | Granted —31.07.2026, no. 2026/301 |
| 2. Pricing and market availability | Assignment of an official selling price, barcode activation, importation, and delivery to pharmacies and hospitals | TİTCK (pricing) + marketing authorization holder (supply) | Completed —drug price list updated 21.09.2026; barcode 8680656080780 active, restricted white prescription |
| 3. Reimbursement | Coverage of the cost by SGK; inclusion in the List of Reimbursable Medicines (EK-4/A) | SGK / Reimbursement Commission | Not found —mirvetuximab soravtansine does not appear in the lists we reviewed; the product is marked "not reimbursed by SGK" in two price-list sources |
In the two months after authorization on July 31, 2026, the second of these three gates opened. With the price-list update dated September 21, 2026 , ELAHERE appeared on the Turkish drug list with its active barcode (8680656080780) and official retail price; the product is sold under "restricted white prescription" status. According to information provided to us, the drug was registered in the Ministry of Health's electronic prescribing system as of September 22, 2026 and can be obtained from pharmacies.
What we could and could not verify: We were able to verify through two independent drug-price sources that the price, barcode, and prescription category appear in official lists. The exact date of registration in the electronic prescribing system and actual pharmacy stock availability could not be confirmed through a publicly available primary source; these two pieces of information came to us from the field. A listing on a drug price list does not mean the product is immediately available in every pharmacy—cytotoxic, imported, high-cost products are usually supplied to order .
Two gates have opened; the third appears closed. Mirvetuximab soravtansine was not found in the List of Reimbursable Medicines announcements we reviewed, and two separate price sources mark the product as "not reimbursed by SGK" . This means that, at present, the cost is paid by the patient . Reimbursement lists are updated frequently; before making a decision, consult your hospital's SGK eligibility and authorization unit and medical board / medicines unit to confirm the current position. Our detailed article on access routes for newly approved medicines in Türkiye, Access in Türkiye to newly FDA-approved cancer drugs , explains the general process.
Price: the figure is now official and verifiable
The most concrete consequence of authorization is that the drug now has an official selling price on the drug price list . Figures circulating before authorization, when the drug had to be sourced from abroad, varied much more with exchange rates and the supply chain. We confirmed the same vial price below in two independent sources reflecting the list as of September 21, 2026 . How oncology drug prices are determined and why they change so frequently are explained in detail in our article on oncology drug prices .
| Item | Amount | Explanation |
|---|---|---|
| Retail price per vial ELAHERE 5 mg/mL concentrate (100 mg in 20 mL) · barcode 8680656080780 |
77,382.53 ₺ | Drug price list—updated 21.09.2026 |
| Typical requirement per cycle (21 days) | 4 vials | For a patient who is 165 cm tall and weighs 80 kg: AIBW 65.9 kg → dose 395 mg |
| Approximate drug cost per cycle | ≈ 309,500 ₺ | 4 × 77,382.53 ₺— our calculation |
| Approximate cost for six cycles | ≈ 1.86 million ₺ | Corresponds to approximately four and a half months of treatment— our calculation |
How to read this table: Only the first row is an official figure; the three rows below it are rough calculationsbased on that figure. Actual cost depends on the patient's height and weight (and therefore how many vials must be opened), treatment duration, any dose reductions, and updates to the price list. Vials are single-use; any remaining amount cannot be used for another patient, resulting in wastage per vial in lower-weight patients. Drug prices in Türkiye are updated following exchange-rate and regulatory changes—confirm the current figure with the hospital pharmacy.
We could not find a source confirming that reimbursement is available ; the two price sources we found mark the product as "not reimbursed by SGK" , and the active ingredient does not appear in the List of Reimbursable Medicines announcements we reviewed. This article therefore does not provide any details such as an SUT code, reimbursement conditions, medical report requirements, or copayment rate —passing on such details without verification could directly harm the patient.
Where to ask: your treating hospital's medical board / medicines unit, its SGK eligibility and authorization unit, the hospital pharmacy, and the treating medical oncology clinic. Reimbursement lists are updated several times a month; information that was correct on the publication date of this article may have changed a week later. Do not rely on outdated information; ask again each time.
Ovarian cancer in Türkiye: the scale—and why two different figures circulate
Turkish-language sources give two different answers to this question: some state 1,745, while others state around 4,000 . Neither is wrong; they count different things , and confusing them produces statements that really are incorrect.
| Source | Figure | What it actually measures |
|---|---|---|
| Republic of Türkiye Ministry of Health Türkiye Cancer Statistics 2020 |
1,745 cases (2020) | The number of cases actually recorded by cancer registries. In 2020, the registration system covered 50.6% of the population—so this is a count of half the country, rather than all of it. |
| IARC—GLOBOCAN 2020 | 4,059 cases (and ~2,730 deaths) |
A model-based estimate produced by applying the rates in the same registries to the country's entire population. It is the "expected" number, rather than the "recorded" number. |
| IARC—new GLOBOCAN version published in 2026 | 3,918 cases | An updated estimate using the same method. It represents 1.7% of the total cancer burden in Türkiye. |
A rough check illustrates this relationship: if registration covers approximately half the population, doubling 1,745 approaches the GLOBOCAN estimate. This is the method itself, rather than a coincidence. When two figures are used side by side in an article, it must be made clear which is a count and which is an estimate. Our article discussing the coverage, reporting delay, and strengths of Türkiye's cancer registration system, Türkiye cancer statistics , explains the reason for this difference.
The same distinction appears in the rankings: the Ministry of Health's own table lists ovarian cancer as the fifth most common cancer among women , whereas the GLOBOCAN 2020 ranking places it seventh . Again, the difference comes from the methods; both indicate that it is "not rare, but not among the top three."
Worldwide, ovarian cancer has an age-standardized incidence rate of 6.6 per hundred thousand (GLOBOCAN 2020; 6.5 in the new version). By income group, this rate varies between 5.3 and 8.0 , and the highest country-level rates can reach around 14 per hundred thousand. For Türkiye, the crude rate is approximately 9.5per hundred thousand (4,059 cases / female population). However, we could not verify the Türkiye-specific age-standardized rate from a primary source and therefore have not reported it. The figure of "14.6 per hundred thousand" previously included in this article could not be found in any primary source and has been removed; for ovarian cancer, that rate would be comparable to the highest national rates in the world and is not realistic for Türkiye.
No published Türkiye-specific estimate exists of how many of these patients will develop platinum-resistant disease, meet the FRα threshold, and have high-grade serous histology. For symptoms, stages, and the general treatment approach, see our ovarian cancer guide; for hereditary risk and preventive surgery, see Preventive surgery in BRCA carriers .
Frequently asked questions
- Is Elahere authorized in Türkiye?
- Yes. Its TİTCK authorization is dated July 31, 2026 , authorization number 2026/301, and the marketing authorization holder is AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Ltd. Şti. The Turkish Summary of Product Characteristics is published in TİTCK's SmPC/leaflet archive. However, authorization does not mean that SGK covers the drug or that it is immediately available at every hospital.
- How much does Elahere cost?
- According to the drug price list updated on September 21, 2026 , the retail price of one vial (100 mg in 20 mL) is 77,382.53 ₺. A typical patient requires four vials per cycle, amounting to approximately 309,500 ₺ per cycle (this second figure is our calculation). Actual cost varies with your height, weight, and treatment duration. Drug prices are updated following exchange-rate and regulatory changes, so confirm the current figure with the hospital pharmacy.
- Can I find it at a pharmacy?
- The product is now on the official price list, its barcode is active, and it is sold with a restricted white prescription ; according to information provided to us, it has been registered in the electronic prescribing system since September 22, 2026 and can be supplied. However, appearing on the price list does not mean it is ready on every pharmacy's shelf: cytotoxic, imported, high-cost products are usually supplied to order . Proceed through your treating hospital's pharmacy.
- Does SGK cover it?
- In the List of Reimbursable Medicines announcements we reviewed, mirvetuximab soravtansine was not found , and two separate price sources mark the product as "not reimbursed by SGK" . At present, the patient therefore bears the cost. These lists are updated several times a month, so before deciding, ask your hospital's SGK eligibility and authorization unit and medical board to confirm the current position.
- Who pays for the FRα test?
- We were informed that the marketing authorization holder had announced free FRα testing support in Türkiye, but we could not verifythis through any publicly available source. Similar programs have operated in other countries (the United States FR-ASSIST program closed to new applications on December 15, 2024). Ask your oncology clinic and pathology laboratory who will cover the test; if you are given a program name, request written confirmation.
- Is Elahere chemotherapy?
- Not exactly, but it contains chemotherapy. It consists of a targeting antibody linked to a cell poison called DM4—the chemotherapy molecule is delivered to its target. It is therefore more selective than conventional chemotherapy and has a different side-effect profile.
- Can every patient with ovarian cancer receive it?
- No. The Turkish indication requires all four conditions: high-grade serous histology, platinum resistance, FRα positivity (2+/3+ staining in ≥75% of tumor cells), and 1-3 prior systemic therapies. It is also inappropriate for patients who never responded to their first platinum therapy (primary platinum-refractory disease).
- Will I lose my hair?
- Hair loss is not among this drug's prominent side effects—an important difference from conventional chemotherapies such as paclitaxel, with which it was compared. Individual variation is possible, however.
- Will my vision loss be permanent?
- In pooled data from 682 patients, among those experiencing an ocular event, 53% had complete resolution and 38% had partial improvement ; at the last follow-up, only 2 patients (0.3%) had an ongoing severe ocular event. However, this reassurance applies when the prevention protocol is followed : baseline and regular eye examinations, the steroid eye-drop schedule, artificial tears, and the contact lens restriction. Skipping the protocol increases risk.
- Will my eyeglass prescription change?
- Temporary blurred vision is common during treatment and does not mean that your eyeglass prescription has permanently changed. Consult your ophthalmologist before obtaining new glasses while treatment is ongoing; the condition usually improves after treatment ends.
- What should I do if I become short of breath?
- Report it without delay. This drug causes inflammation of lung tissue (pneumonitis) in 10% of patients, and deaths from respiratory failure have been reported in clinical trials. Onset is usually around the fourth month of treatment. New or worsening cough, shortness of breath, and fatigue that increases with exertion should not be dismissed as "the cancer is progressing"; lung imaging should be requested.
- My FRα test was negative. Do I have other options?
- Yes. FRα negativity rules out Elahere, but not other treatments. In platinum-resistant disease, options to consider include single-agent chemotherapy (pegylated liposomal doxorubicin, weekly paclitaxel, topotecan, gemcitabine), adding bevacizumab, PARP inhibitors for an appropriate genetic profile, and clinical trials.
- Where can I have the test? Do I need a new biopsy?
- The test is an immunohistochemical examination of tumor tissue in a stored paraffin block; a new biopsy is usually unnecessary. The SmPC requires an appropriate CE-marked in vitro diagnostic test , or a validated alternative if unavailable. Ask to see which criterion was used in the report (2+/3+ membrane staining in ≥75% of tumor cells).
- I have platinum-sensitive disease. Can I use it?
- The approved indication is limited to platinum-resistant disease. Phase 2 data presented in 2026 showed a response rate as high as 62% in platinum-sensitive disease, but this was a single-arm study and results from the randomized GLORIOSA study have not yet been announced. Effective options already exist for this group; this use is currently outside the indication.
- How many cycles will I receive?
- There is no fixed number of cycles. Treatment continues every three weeks until disease progression or unacceptable toxicity. Median treatment duration in clinical trials was 19.1 weeks.
- Can I drive during treatment?
- Blurred vision and light sensitivity can affect driving; the antihistamine used for premedication can also cause drowsiness. Do not drive, particularly on infusion days or while experiencing visual symptoms.
- I take other medicines. Could that be a problem?
- Possibly. The drug's cytotoxic payload, DM4, is broken down by the CYP3A4 enzyme in the liver; medicines that strongly inhibit this enzyme (certain antifungals, antibiotics, and HIV medicines) may increase the risk of side effects. Tell your oncology team about all prescription, nonprescription, and herbal products.
Glossary
- Antibody-drug conjugate (ADC)
- A drug consisting of a targeting antibody chemically linked to a cell poison. A "guided" system that delivers chemotherapy to the tumor.
- Folate receptor alpha (FRα)
- A protein overexpressed on the surface of certain tumor cells but present only to a very limited extent in normal tissues. This is Elahere's target.
- DM4
- A microtubule poison in the maytansinoid class. It stops cell division by preventing formation of the cellular skeleton. In Elahere, an average of 3.4 molecules are attached to each antibody.
- Summary of Product Characteristics (SmPC)
- The official TİTCK-approved document defining how a medicine is used in Türkiye. It is the binding reference for physicians.
- Medicine subject to additional monitoring
- A medicine whose safety profile is closely monitored, marked by an inverted black triangle in its labeling. Side effects are expected to be reported to TÜFAM.
- High-grade serous carcinoma
- The most common and most aggressive epithelial subtype of ovarian cancer. The Turkish indication is limited to this histology.
- Platinum resistance
- Disease progression within 6 months after completion of platinum-containing chemotherapy.
- Primary platinum-refractory disease
- No response to the first platinum therapy or progression while it is ongoing. Elahere is not appropriate for this group.
- Objective response rate (ORR)
- The percentage of patients whose tumors measurably shrink on imaging. It measures tumor shrinkage, rather than survival.
- Progression-free survival (PFS)
- The length of time without disease progression. It is an intermediate endpoint.
- Overall survival (OS)
- Survival itself. It is the strongest and least disputed endpoint in oncology.
- Hazard ratio (HR)
- A number comparing risk between two arms. A value below 1 favors the new treatment; an HR of 0.67 roughly means "a 33% reduction in event risk."
- Keratopathy
- Damage to the cornea (the transparent front layer of the eye). It may cause blurred vision, stinging, and sensitivity to light.
- Uveitis
- Inflammation of the middle layer of the eye. It causes pain, redness, and reduced vision.
- Pneumonitis
- Inflammation of lung tissue from noninfectious causes. It begins with cough and shortness of breath; severe cases may be life-threatening.
- Adjusted ideal body weight (AIBW)
- An adjusted weight calculated from height, used instead of actual weight to calculate the dose. It prevents both overdosing and underdosing.
- Boxed warning
- The highest level of safety warning for a medicine. It means special precautions are required, rather than that the drug is prohibited.
- CE-marked IVD
- An in vitro diagnostic test with documented conformity to European legislation. The FRα test is expected to meet this standard.
DROZDOGAN Academy Commentary
Most Turkish-language texts about Elahere correctly explain its mechanism but omit three critical facts: why it represents a historic breakthrough, why the Turkish indication is narrower than the United States indication, and why eye protection is mandatory.
⚡ Why it matters
For twenty years, platinum-resistant ovarian cancer was an area in which new drugs failed one after another. No agent approved during that time could prolong overall survival in a randomized trial. MIRASOL was the first study to break this barrier—16.46 versus 12.75 months, HR 0.67. Moreover, this gain came not with a more severe but with a milder toxicity profile. With TİTCK authorization on July 31, 2026 and entry on the price list in September 2026, this option can now be prescribed in Türkiye both legally and in practice. The question has shifted from "is the drug available?" to "is it being given to the right patient, with the right protocol, and at what cost?" .
✅ Strengths
The evidence chain is exemplary: accelerated approval was based on a small phase 2 study; the confirmatory phase 3 trial was conducted on time and was positive —the frequently criticized weak point of the accelerated approval system worked here. The response-rate difference is substantial (42.3% versus 15.9%); while no chemotherapy patient achieved a complete response, tumors disappeared completely on imaging in 12 Elahere patients. There is an unexpected toxicity advantage: severe side effects in 41.7% versus 54.1%, and treatment discontinuation in 9.2% versus 15.9%. Patient selection relies on a test with a defined threshold, rather than guesswork. The Turkish SmPC describes the eye protection protocol in day-by-day detail, giving the treating team a clear roadmap.
⚠️ Limitations
The benefit is real but modest: a median survival gain of 3.7 months; the disease is not cured. The drug can be used only in patients meeting all four requirements—high-grade serous histology, platinum resistance, the FRα threshold, and 1-3 prior lines; patients with primary platinum-refractory disease are explicitly excluded. This represents only a subset of platinum-resistant patients. Ocular toxicity carries a boxed warning and demands disciplined adherence from patients; ocular side effects led to dose delays in 24% and dose reductions in 15% of patients, making them the main practical obstacle to treatment continuity. Pneumonitis must be taken seriously: its frequency is 10%, and two deaths from respiratory failure occurred in clinical trials. Finally, two sections of the Turkish SmPC give different eye-examination frequencies, a wording problem that may cause confusion in practice.
🩺 What to do in practice
- If treatment is being considered, first have the pathology report checked: is the histology high-grade serous, and does the FRα report use the criterion of 2+/3+ staining in ≥75% of cells?
- Clarify whether the first platinum treatment produced a response— platinum-resistant and primary platinum-refractory are different, and the drug is not appropriate for the latter.
- Before starting treatment, arrange an ophthalmologist appointment ; this examination is part of treatment. Ask for a slit-lamp examination.
- Start steroid eye drops one day before infusion : 6 times daily through day 4, then 4 times daily on days 5-8. Apply artificial tears at least 10 minutes after the steroid drops.
- Throughout treatment, do not wear contact lenses.
- For these four symptoms, do not wait until your next appointment: blurred vision, sensitivity to light, numbness in the hands or feet, and new cough or shortness of breath. All four may require dose modification.
- It is worth reminding your team of two technical preparation details: dilution uses 5% glucose (the drug is incompatible with normal saline), and administration must use a PES in-line filter .
- For access in Türkiye, ask separately about authorization, pricing/market availability, and reimbursement ; one does not guarantee the others. As of September 2026, the first two were complete, but we found no verified reimbursement record.
- Clarify who will pay for the FRα test when deciding on treatment. If you hear about company support, obtain written confirmation of the program's name, scope, and duration—there is no verified publicly available source on this.
❓ Open questions
What will randomized GLORIOSA results show in platinum-sensitive disease, and can the drug move to earlier treatment lines? Is there truly no benefit for patients below the FRα threshold with low-to-moderate expression, or is the threshold too strict? What sequence makes sense after resistance develops? How well is the eye protection protocol followed in real-world practice, and how much does adherence affect outcomes? For Türkiye specifically, now that market availability is established, reimbursement is the next question: will the drug enter the List of Reimbursable Medicines, under what conditions, and when? How many patients can realistically access a product costing 77 thousand lira per vial without reimbursement? At which centers nationwide will FRα testing be offered, to what standard, and who will pay? A drug reaching pharmacy shelves does not mean its test is accessible—this is the real bottleneck ahead.
Our brief verdict: Elahere prolonged survival in platinum-resistant ovarian cancer, achieving what no drug had accomplished in twenty years, and did so with a milder toxicity profile than chemotherapy. With authorization on July 31, 2026 and price-list entry in September 2026, it can now be prescribed in Türkiye in practice—but, according to the records we found, reimbursement has not yet become available. This is not a drug to simply "prescribe and administer": it requires selection using four separate criteria, eye protection following a day-by-day protocol, and close lung monitoring. The drug's success cannot be separated from the treating team's discipline.
The administration, dosing, safety, and indication information in this article comes from the Turkish Summary of Product Characteristics approved by TİTCK . Points we could not verify or deliberately did not report:
- The selling price, barcode, and prescription category were verified consistently in two independent drug-price sources (list updated 21.09.2026). The cycle and treatment cost calculations are our own and vary between patients; prices are updated following exchange-rate and regulatory changes.
- The date of registration in the electronic prescribing system (September 22, 2026) and actual pharmacy availability were reported to us from the field; no publicly available primary source for these two details was found. The price-list update dated 21.09.2026 is consistent with this information but does not substitute for it.
- A company announcement about providing free FRα testing support in Türkiye was reported to us; it could not be verified through any publicly available source. The program's scope, application process, and duration are therefore not reported. Similar programs in other countries could be verified (the United States FR-ASSIST program closed to new applications on December 15, 2024).
- SGK reimbursement: The active ingredient was not found in the List of Reimbursable Medicines announcements we reviewed, and two price sources marked the product "not reimbursed by SGK." This is a negative finding, rather than documentation of an official rejection; details such as an SUT code, reimbursement conditions, and copayments have not been provided.
- The TİTCK authorization number (2026/301) and date (31.07.2026) were taken from the SmPC; they could not be independently confirmed because TİTCK's online records were inaccessible from this environment. The marketing authorization holder's name was verified by the price sources.
- Inconsistency within the SmPC: Eye-examination frequency is described as "every other cycle during the first 8 cycles" in the boxed warning and Section 4.2, but "before every cycle during the first 8 cycles" in Section 4.4. This discrepancy has been disclosed in the article, with the decision left to the treating team.
- Proportion of FRα-high patients: There is no single authoritative figure; results from two separate studies (43.5% and 50.7%) are provided, while the frequently repeated online figure of "35%" was not used because it could not be verified.
- Centers offering FRα testing in Türkiye: No publicly available list was found.
- GLORIOSA phase 3 results: Not yet announced; the study is active but closed to recruitment.
- Efficacy data (MIRASOL and SORAYA figures) were obtained from primary publications and regulatory announcements, rather than the SmPC; adverse-event rates come from the SmPC's pooled dataset of 682 patients. As these sources involve different populations, their rates do not match exactly.
- The pool of patients in Türkiye with platinum-resistant, high-grade serous, FRα-positive disease: No published official estimate exists, so no figure is given.
- Epidemiology correction: The previous version of this article stated "approximately 1,745 new cases per year" and "an age-standardized incidence rate of 14.6 per hundred thousand" for Türkiye. Review showed that both had been used incorrectly: 1,745 is the number of cases recorded in the population covered by cancer registries (50.6% in 2020), rather than a national estimate; "14.6" could not be found in any primary source and is unrealistically high for ovarian cancer. The text has been revised to distinguish clearly between the GLOBOCAN estimate (4,059) and the registry count (1,745). We thank the reader who brought this correction to our attention.
- The Türkiye-specific age-standardized incidence rate could not be verified from a primary source and has therefore not been reported. The stated value of 6.6 is the global rate; 9.5 is Türkiye's crude rate. They are not interchangeable. The "regional range of 3.0-11.4" cited by some sources was also not used because it relied on a publication inaccessible during this review; the verifiable income-group range (5.3-8.0) was used instead.
- The diagramsare derived from verified statements in the text and contain no new data.
- Nothing in this article replaces personal medical advice or constitutes a treatment recommendation. Treatment decisions are made with your medical oncologist, who knows your diagnosis and complete medical history. The drug must be initiated and supervised by a physician experienced in the use of anticancer medicines.
References
- ELAHERE 5 mg/mL infüzyonluk çözelti hazırlamak için konsantre — Kısa Ürün Bilgisi. T.C. Sağlık Bakanlığı, Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). Authorization no. 2026/301; initial authorization date 31.07.2026. Marketing authorization holder: AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Ltd. Şti.
- TİTCK. Kısa Ürün Bilgisi / Kullanma Talimatı archive: titck.gov.tr/kubkt
- Moore KN, Angelergues A, Konecny GE, et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer (MIRASOL). N Engl J Med. 2023;389(23):2162-2174. doi:10.1056/NEJMoa2309169
- Matulonis UA, Lorusso D, Oaknin A, et al. Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. J Clin Oncol. 2023;41(13):2436-2445. doi:10.1200/JCO.22.01900
- U.S. Food and Drug Administration. FDA grants accelerated approval to mirvetuximab soravtansine-gynx. November 14, 2022.
- AbbVie. FDA Grants Full Approval for ELAHERE. Press release, March 22, 2024.
- AbbVie. European Commission Approval of ELAHERE. Press release, November 18, 2024.
- AbbVie. Late-Breaking Phase 2 Data in Platinum-Sensitive Ovarian Cancer, SGO 2026. Press release, April 12, 2026.
- Borowczak J, et al. Folate receptor alpha expression in platinum-resistant ovarian cancer: a multicenter study. Clin Transl Oncol. 2026;28:2143-2149.
- GLORIOSA trial registration, NCT05445778. ClinicalTrials.gov.
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay product information, Roche Diagnostics.
- T.C. Sağlık Bakanlığı, Halk Sağlığı Genel Müdürlüğü. Türkiye Kanser İstatistikleri 2020. Ankara. (Cancer registry coverage as of 2020: 50.6%; recorded ovarian cancer cases: 1,745.)
- International Agency for Research on Cancer. Global Cancer Observatory—Türkiye and ovarian cancer fact sheets (GLOBOCAN). gco.iarc.who.int
- Türk Jinekolojik Onkoloji Derneği. Yumurtalık Kanserini Anlamak—patient information document. (According to GLOBOCAN 2020, 4,059 cases per year in Türkiye.)
- World Ovarian Cancer Coalition. Every Woman Study—Global Atlas 2023. (Global age-standardized incidence rate: 6.6/100,000; by income group: 5.3-8.0.)
- Roche. Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Press release, November 18, 2024.
- Turkish drug price list records—ELAHERE 5 mg/mL concentrate, barcode 8680656080780; list updated 21.09.2026 (verified through ilacabak.com and ilacfiyati.com).
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