What Is Dostarlimab (Jemperli)? FDA Approval, Licensing and Reimbursement in Turkey
| Active ingredient | Dostarlimab (dostarlimab-gxly) |
| Brand name | Jemperli |
| Class | PD-1 inhibitor (immune checkpoint inhibitor, humanized IgG4 monoclonal antibody) |
| Category | Immunotherapy |
| Route of administration | Intravenous infusion (approximately 30 minutes) |
| Dosing frequency | 500 mg IV every 3 weeks (4 doses) → followed by maintenance at 1000 mg IV every 6 weeks |
| FDA-approved cancers | Primary advanced or recurrent endometrial cancer (with carboplatin+paclitaxel, in all patients regardless of MMR/MSI status), dMMR/MSI-H advanced/recurrent endometrial cancer (monotherapy), dMMR advanced solid tumors (tumor-agnostic monotherapy) |
| Investigational indication | dMMR/MSI-H locally advanced rectal cancer — it has received FDA Breakthrough Therapy Designation (December 2024), but it is not yet an approved indication |
| FDA approved | Yes (initial accelerated approval on April 22, 2021; converted to full approval in February 2023) |
| Manufacturer | GlaxoSmithKline (GSK) |
| License from Turkey's Ministry of Health | YES — listed in TİTCK's licensed products list (for the dMMR/MSI-H endometrial cancer indication) |
| SGK reimbursement | NO — although licensed, it is not yet on the List of Reimbursable Medicines (annex to the Health Implementation Communiqué, SUT) |
| Price of Jemperli 500 mg/10 mL | ≈ ₺174577.08 (current retail price in Turkish drug price databases, updated periodically) |
| Elimination half-life | Approximately 25 days (enabling Q6W maintenance dosing) |
Dostarlimab (Jemperli) is a PD-1 inhibitor that restores T cells' capacity to fight tumors by blocking the PD-1 receptor. It is particularly effective in tumors with deficient DNA mismatch repair (dMMR) or high microsatellite instability (MSI-H) and has become a central component of first-line treatment for endometrial (uterine) cancer.
This monograph covers its mechanism, FDA/EMA approval history, clinical data from the RUBY trial, dosing protocol, safety profile, and current licensing, SGK reimbursement and pricing in Turkey . This version was prepared by removing formatting problems from the earlier draft (code remnants and repeated labels) and cross-checking price and access information against verifiable sources.
Normally, the PD-1/PD-L1 axis acts as a "brake" limiting excessive and harmful immune activation. Many tumors exploit this pathway by increasing surface expression of PD-L1/PD-L2 and suppressing the T-cell response.
Dostarlimab binds to PD-1 with high affinity, preventing its interaction with PD-L1/PD-L2. This reactivates tumor-specific T cells, increases the release of cytokines such as IFN-γ and strengthens cytotoxic responses in the tumor microenvironment.
Defects in DNA repair cause many mutations and neoantigens to accumulate, making the tumor easier for the immune system to recognize. PD-1 inhibitors such as dostarlimab can produce particularly high response rates in these immunogenic tumors. Determining dMMR/MSI-H status with a validated test (IHC, PCR or NGS) before treatment is therefore critical.
| Date | Authority | Indication / decision |
|---|---|---|
| April 2021 | FDA | For dMMR advanced/recurrent endometrial cancer after platinum therapy, accelerated approval as monotherapy |
| April 2021 | European Commission | For dMMR/MSI-H advanced/recurrent endometrial cancer, conditional marketing authorization (monotherapy after platinum therapy) |
| August 2021 | FDA | For dMMR advanced solid tumors after platinum therapy when no suitable alternative is available, tumor-agnostic accelerated approval |
| February 2023 | FDA | Conversion of monotherapy approval for dMMR advanced/recurrent endometrial cancer to full approval . |
| July 2023 | FDA | RUBY Part 1 data supported approval with carboplatin+paclitaxel for dMMR/MSI-H primary advanced/recurrent endometrial cancer |
| August 1, 2024 | FDA | Expansion of the combination indication to all patients with primary advanced/recurrent endometrial cancer regardless of MMR/MSI status |
| January 2025 | European Commission | Expansion of combination approval in endometrial cancer, based on RUBY data, to all patients with primary advanced/recurrent disease . |
| December 2024 | FDA (BTD) | For dMMR/MSI-H locally advanced rectal cancer, Breakthrough Therapy Designation — not yet a licensed indication; based on strong phase 2 data |
- RUBY Part 1 showed that dostarlimab plus carboplatin/paclitaxel significantly improved both progression-free and overall survival compared with chemotherapy alone, with a particularly pronounced effect in the dMMR/MSI-H subgroup.
- These results have placed dostarlimab at the center of first-line systemic treatment regimens for endometrial cancer.
Loading (induction) phase: 500 mg IV as a 30-minute infusion every 3 weeks, for a total of 4 doses as monotherapy; with carboplatin+paclitaxel for 6 cycles in combination treatment.
Maintenance phase: 1000 mg IV as a 30-minute infusion every 6 weeks, continued until disease progression or unacceptable toxicity.
After chemotherapy is completed in the combination regimen, dostarlimab is continued alone as maintenance. Close monitoring for infusion reactions during the initial infusions and, if needed, antihistamine ± antipyretic premedication may be used.
Possible resistance mechanisms include overexpression of other immune checkpoints (TIGIT, TIM-3, LAG-3), increased immunosuppressive cell populations such as Tregs/MDSCs, activation of immunosuppressive molecules such as TGF-β/IL-10/adenosine, and impaired antigen presentation due to loss of HLA class I or β2-microglobulin mutations.
- General: Fatigue, weakness, loss of appetite and mild fever.
- Gastrointestinal: Nausea, diarrhea and abdominal pain.
- Hematologic: Anemia and lymphopenia, generally mild to moderate.
- Skin: Rash and itching.
- Musculoskeletal: Joint and muscle pain.
- Pneumonitis: Dry cough, shortness of breath and hypoxia — high-dose steroids and treatment interruption may be needed.
- Colitis: Frequent or bloody diarrhea and abdominal pain — systemic steroids or a biological agent such as infliximab may be considered in moderate to severe cases.
- Hepatitis: Elevated AST/ALT and bilirubin; close biochemical monitoring is required.
- Nephritis: Elevated creatinine and proteinuria.
- Endocrinopathies: Hypothyroidism/hyperthyroidism, hypophysitis, adrenal insufficiency and type 1 diabetes — usually permanent and requiring long-term hormone replacement.
- TSH, free T4, cortisol, liver and kidney function tests, and complete blood counts should be monitored regularly before and during treatment.
- Grade 3-4 toxicity generally requires permanent discontinuation. For suspected immune-related toxicity, starting steroids should be considered according to the CTCAE grade.
Licensing status: Dostarlimab (Jemperli) is licensed by TİTCK in Turkey and is now available from pharmacies on a standard prescription (White Prescription). This is a current development that differs from earlier information that the drug was unlicensed.
Indication: The licensed indications in Turkey are limited to use with carboplatin+paclitaxel for dMMR/MSI-H newly diagnosed stage IV or recurrent endometrial cancer and use as monotherapy for dMMR/MSI-H advanced endometrial cancer progressing after platinum therapy . Whether the US/EU expansion to "all patients regardless of MMR status" is reflected in the Turkish license should be confirmed in the current Summary of Product Characteristics (SmPC).
Reimbursement: Although licensed, it is not yet on SGK's List of Reimbursable Medicines (SUT annex). Access is largely possible through patients paying themselves or recovering the cost from SGK following an administrative court decision.
Turkish drug price databases list the current retail price of a Jemperli 500 mg/10 mL vial as approximately ₺174577.08 . This figure may change with TİTCK's periodic price updates. Patients planning treatment are advised to confirm the current, binding price with the prescribing hospital's pharmacy or the relevant pharmacy. Total treatment costs for combination or maintenance regimens vary substantially with the dose used (500 mg versus 1000 mg) and total number of cycles.
Dostarlimab (Jemperli) is an immunotherapy drug that turns off the PD-1 "brake" cancer cells use to hide from the immune system. This allows the body's defense cells to recognize and attack cancer cells again.
It is used particularly in advanced or recurrent endometrial cancer and certain other cancers with a specific genetic feature (dMMR/MSI-H). It is usually a long-term treatment given intravenously every 3-6 weeks.
- Find out your tumor's dMMR/MSI-H status. Suitability for this treatment is determined using a validated laboratory test.
- Be aware that it is now licensed in Turkey but not yet reimbursed by SGK. Speak to the hospital's social services or patient rights unit in advance to plan costs.
- Recognize urgent symptoms: Report symptoms such as shortness of breath, severe diarrhea, high fever, jaundice or severe muscle weakness to your doctor immediately.
- Always make the treatment decision together with your medical oncologist after assessing your general condition, other illnesses and the genetic characteristics of your tumor.
Dostarlimab offers some of the clearest clinical evidence of the exceptional sensitivity of dMMR/MSI-H tumors to immunotherapy. Its establishment as a standard component of first-line endometrial cancer treatment after RUBY is a tangible example of success for biomarker-driven immunotherapy.
FDA approvals expanded gradually from 2021 to 2024, and the combination indication now covers all patients with primary advanced/recurrent endometrial cancer regardless of MMR status. It is licensed in Turkey, but SGK reimbursement is not yet available, and the current vial price is approximately ₺161148.22.
Although striking early results in rectal cancer, including complete responses in small patient series, are exciting, this is not yet an approved indication and has only reached Breakthrough Therapy Designation status. Whether Turkey's licensed indication matches the broadest US/EU scope (regardless of MMR status) should be confirmed in the current SmPC. The lack of SGK reimbursement creates a major access and cost barrier for patients.
Before treatment, dMMR/MSI-H status must be established with a validated test. Availability by prescription in Turkey now facilitates access, but because SGK does not reimburse it, costs must be discussed openly with patients before treatment.
When will dostarlimab be added to SGK's List of Reimbursable Medicines? Will Breakthrough Therapy Designation in rectal cancer become full FDA approval? Will the scope of Turkey's licensed indication be aligned with the latest US/EU expansion to all patients regardless of MMR status?
- Mirza MR, et al. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. N Engl J Med. 2023;388:2145-2158 (RUBY Part 1).
- GSK. US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer. Press release, August 1, 2024.
- GSK. European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer. Press release, January 2025.
- FDA. JEMPERLI (dostarlimab-gxly) Prescribing Information; Drugs.com approval history.
- EMA. Jemperli EPAR — Product Information (Summary of Product Characteristics).
- GSK. Jemperli (dostarlimab) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer. Press release, 2024.
- Turkish drug price database — current retail price of Jemperli 500 mg/10 mL and TİTCK ATC record.
- Turkish Medicines and Medical Devices Agency and SGK announcements; SUT/EK-4 reimbursement lists and current legislation.
Sources
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