Selpercatinib (Tanstrive, Retevmo, Retsevmo): FDA Approval, Licensing in Türkiye, and Reimbursement Status
In this article
| Active ingredient | Selpercatinib (selpercatinib) |
| Brand name in Türkiye | TANSTRIVE 40 mg and 80 mg hard capsules |
| Other brand names | Retevmo (United States) · Retsevmo (EU/EMA) |
| ATC code | L01EX22 |
| Class | Signal transduction inhibitor — selective RET inhibitor |
| Category | Oral targeted agent |
| Administration | Oral hard capsule |
| Dosing frequency | Twice daily (~12 hours apart), at a fixed dose based on body weight: <50 kg → 120 mg, ≥50 kg → 160 mg (TİTCK SmPC, Section 4.2) |
| TİTCK-approved indications (Türkiye) | RET fusion-positive NSCLC (adults, no previous RET inhibitor) · RET fusion-positive differentiated thyroid cancer (adults + children over 12 years) · RET fusion-positive anaplastic thyroid cancer (adults) · RET-mutated MTC (adults + children over 12 years) — NO tumor-agnostic solid tumor indication in the Turkish license |
| FDA-approved indications (United States) | Yes — first approval May 8, 2020; latest milestone July 14, 2026 (full approval for tumor-agnostic RET+ solid tumors + expansion to children over 2 years — this expansion applies only in the United States) |
| Manufacturer / marketing authorization holder | Eli Lilly and Company · Turkey: Lilly İlaç Ticaret Ltd. Şti. |
| TİTCK license | YES — March 26, 2026 (previously available only through procurement from abroad) |
| SGK reimbursement | NO |
| Prescription status (Türkiye) | Restricted/classified white prescription |
| Half-life | ~32 hours |
Selpercatinibis an oral RET gene alteration -targeted treatment for certain cancers. It is a RET inhibitor. In the United States, it is approved for RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutated medullary thyroid cancer (MTC), RET fusion-positive thyroid cancer, and, regardless of the organ of origin, all solid tumors carrying a RET fusion (a tumor-agnostic indication).
The TİTCK license in Türkiye has a narrower scope: In Türkiye, TANSTRIVE is approved only for NSCLC, differentiated/anaplastic thyroid cancer, and RET-mutant MTC. The Turkish license does not include a tumor-agnostic solid tumor indication or pediatric expansion below 2 years. This monograph examines the latest FDA approval history and the actual TİTCK indication wording separately.
RET (“REarranged during Transfection”) encodes a receptor tyrosine kinase that normally regulates cell growth. A fusion (an abnormal joining to another gene) or mutationin this gene keeps growth signals continuously switched on, causing cells to divide without stopping.
Selpercatinibis an oral agent that blocks wild-type RET and numerous mutated RET isoforms. It is a small-molecule selective RET inhibitor. It also affects kinases such as VEGFR1, VEGFR3, and FGFR1/2/3, but only at much higher concentrations, making it primarily selective for RET.
- RET fusions occur in approximately 1–2%of patients with NSCLC.
- RET mutations occur in ~60%of sporadic medullary thyroid cancers and more than 90% of hereditary (familial) cases.
- These groups account for most cancers with RET alterations. RET fusions also occur rarely in other solid tumors, including pancreatic and colon cancers.
The TANSTRIVE license in Türkiye does not include a tumor-agnostic solid tumor indication , and pediatric use is restricted to ages 12 and above . The United States age threshold of 2 years does not apply in Türkiye. The following lists differ; readers must distinguish which country's license they are consulting.
🇹🇷 Türkiye — Approved Indications in the TİTCK Summary of Product Characteristics (SmPC)
- RET fusion-positive NSCLC: Monotherapy for locally advanced or metastatic non-small cell lung cancer in adult patients who have not previously received a RET inhibitor.
- RET fusion-positive differentiated thyroid cancer: For locally advanced differentiated thyroid carcinoma unsuitable for surgery/radiotherapy, or metastatic disease, that has progressed during or after previous VEGF-targeted systemic treatment (sorafenib and/or lenvatinib) and is refractory to radioactive iodine (RAI), in adults and children over 12 years as monotherapy.
- RET fusion-positive anaplastic thyroid cancer: After at least one systemic treatment line, in adult patients.
- RET-mutated medullary thyroid cancer (MTC): For advanced or metastatic disease requiring systemic therapy, in adults and children over 12 years as monotherapy. Requirement: The latest scan before starting TANSTRIVE, compared with an earlier scan performed within 14 months, must show radiological progression .
- The tumor-agnostic indication covering any RET fusion-positive solid tumor is absent from the TİTCK SmPC and is specific to United States FDA approval.
- In Türkiye, pediatric use is defined only for thyroid cancer and MTC in patients aged 12 years and older ; the NSCLC indication is limited to adults. The SmPC explicitly states: “TANSTRIVE must not be used in children younger than 12 years.”
🇺🇸 United States — The FDA's Broader Approved Scope
- Locally advanced or metastatic RET fusion-positive NSCLC (adults).
- Advanced/metastatic RET-mutated MTC requiring systemic treatment (adults and children over 2 years).
- Advanced/metastatic, RAI-refractory RET fusion-positive thyroid cancer (adults and children over 2 years).
- Locally advanced/metastatic RET fusion-positive solid tumors — tumor-agnostic, after progression despite prior systemic treatment or without satisfactory alternatives (adults and children over 2 years; fully approved since July 14, 2026).
- In both countries, selpercatinib is meaningful only when a tumor RET fusion or mutation is confirmed . This requires an approved laboratory test, such as comprehensive genomic testing using next-generation sequencing (NGS).
- RET alterations are rare; without testing, suitability for this treatment cannot be determined.
- Selpercatinib and pralsetinib (Gavreto)are both selective RET inhibitors. Both are used for RET fusion-positive NSCLC and RET-mutated MTC.
- No randomized head-to-head comparison has been performed. Selection generally depends on safety profile, dosing frequency, and availability.
- Selpercatinib is taken twice daily and pralsetinib once daily, a practical difference that may affect adherence.
- Resistance mechanisms overlap (see below). Switching between RET inhibitors after resistance may not always work, particularly with solvent-front mutations.
Although selpercatinib effectively targets RET alterations, some patients develop secondary mutations over time, causing resistance:
- RET solvent-front mutations (G810R, G810S, G810C): Occur in the structural region where the drug binds, making binding more difficult. This is among the most common resistance pathways.
- RET V804M gatekeeper mutation: Alters a critical position controlling access to the target, preventing binding.
Responses may diminish as resistance develops, prompting consideration of next-generation RET inhibitors. Only the oncology team should decide on treatment changes.
| Absorption | Peak levels at an average of ~2 hours. Oral bioavailability ~73%. Steady state after ~7 days. Food does not substantially affect absorption. |
|---|---|
| Distribution | Plasma protein binding ~96%. |
| Metabolism and Elimination | Mainly metabolized by hepatic CYP3A4. Approximately ~70% is eliminated through the hepatobiliary route and ~24% in urine. Terminal half-life ~32 hours. |
- Increase drug levels (CYP3A4 inhibitors): Ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, telithromycin, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, and nefazodone may increase toxicity risk.
- Reduce drug levels (CYP3A4 inducers): Phenytoin, carbamazepine, phenobarbital, rifampin, and St. John's wortmay reduce effectiveness.
- Acid-reducing medicines: If used with a proton pump inhibitor (PPI), TANSTRIVE must be taken with food . With H2 receptor antagonists, TANSTRIVE must be administered 2 hours before or 10 hours after them (TİTCK SmPC, Section 4.5).
- Liver: Monitor LFTs regularly before treatment and during the first 3 months. Severe liver impairment may require dose reduction.
- Blood pressure (hypertension) and QT prolongation: Require regular monitoring.
- Hypersensitivity: Stop the drug for severe reactions. Literature describes a selpercatinib-specific delayed hypersensitivity syndrome involving fever, rash, and elevated transaminases.
- Bleeding, tumor lysis syndrome, thyroid dysfunction and, in children, slipped capital femoral epiphysis (SCFE) are among the less frequent but serious warnings in the product information.
- Surgery: Treatment may need to be interrupted for a specified period before/after surgery because of impaired wound healing risk.
- Pregnancy: Embryofetal toxicity requires caution; patients of reproductive age need medical guidance on contraception.
- License: Selpercatinib was licensed in Türkiye as TANSTRIVE on March 26, 2026by TİTCK. Lilly İlaç Ticaret Ltd. Şti. holds the license for 40 mg and 80 mg hard capsules. The ATC code is L01EX22, and it is sold under a restricted white prescription .
- Market access: Following licensing, the medicine entered the market and drug databases with barcode and pack information. It is therefore now available directly in Türkiye, alongside the previous route of procurement from abroad.
- Current drug price and reimbursement tracking sources show that TANSTRIVE was not covered by SGK when this article was prepared .
- Licensing does not automatically mean SGK reimbursement . These are separate processes, and reimbursement requires a separate SUT/Healthcare Services Pricing Commission decision. This stage is common for many newly licensed targeted cancer medicines.
- Price: TANSTRIVE 40 mg packs are listed at 28600 TL, and TANSTRIVE 80 mg packs at approximately 57046.56 TL. For exact, current prices and reimbursement information, consult a pharmacist, SGK's SUT annex lists, or TİTCK's official drug price list, since these figures can change frequently and rapidly..
Selpercatinib (in Türkiye, TANSTRIVE) is appropriate only for patients whose tumors have a RET gene alteration . It is an oral targeted cancer medicine, and before it can be used, a genetic test must demonstrate the RET alteration.
The medicine is now licensed in Türkiye and available through pharmacies/hospitals. However, SGK did not cover it when this article was prepared , so patients may be charged even with a prescription. Reimbursement status can change; confirm current information with your pharmacist or oncology team. Only the oncology team familiar with your case should decide whether it is suitable, the dose, and the duration of treatment.
Cancers with RET alterations are rare but form a subgroup amenable to highly targeted treatment once identified. As one of the first RET inhibitors with tumor-agnostic approval in the United States, selpercatinib has a broad scope of use. Licensing in Türkiye is an important access milestone but does not resolve either the narrower indication scope, excluding tumor-agnostic use, or reimbursement.
LIBRETTO-001 and subsequent studies demonstrate high, durable response rates in RET fusion-positive NSCLC and RET-mutated MTC. FDA approval history reflects a mature dataset progressing from accelerated to full approvals. The latest step, in July 2026, granted full approval to the tumor-agnostic indication and expanded pediatric scope.
In Türkiye, the difference between licensing and reimbursement is the most practical limitation: Licensing does not guarantee free or affordable access. In addition, the Turkish license is narrower than the United States license . TİTCK does not include tumor-agnostic solid tumors; pediatric use is limited to ages 12 and above; and thyroid cancer requires previous VEGF-targeted treatment with sorafenib/lenvatinib. RET testing may not be routine at every center, creating another access barrier. Resistance mechanisms such as G810 and V804M may limit responses over time.
Suitable candidates are patients within the relevant indications whose RET fusion/mutation is confirmed by NGS. Liver/kidney function, blood pressure, and QT assessment before treatment and regular monitoring are essential. Before prescribing in Türkiye, explaining current reimbursement status and possible out-of-pocket costs must be integral to treatment planning. The reimbursement process should be followed, with updates communicated to readers.
When will TANSTRIVE receive SGK coverage, and which indications or conditions would it cover? Will selpercatinib and pralsetinib, both RET inhibitors, differ in access or price in Türkiye? What is the plan for access to second-generation RET inhibitors after resistance?
- This document does not provide detailed dosing or dose-adjustment information and does not recommend any treatment regimen.
- Selpercatinib is meaningful only in patients with a confirmed RET alteration; comprehensive genomic testing is essential.
- It is licensed by TİTCK in Türkiye (March 26, 2026), but SGK reimbursement was NOT available when this article was prepared . These are independent matters and may change over time.
- Prices could not be independently verified against an official source ; consult a pharmacist/SUT/TİTCK for current, definitive information.
- Only the oncology team familiar with the patient should decide on its use.
- U.S. FDA. FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors. July 14, 2026. fda.gov.
- U.S. FDA. FDA approves selpercatinib for medullary thyroid cancer with a RET mutation. September 27, 2024. fda.gov.
- TİTCK Kısa Ürün Bilgisi (KÜB) — TANSTRIVE 80 mg sert kapsül, Lilly İlaç Ticaret Ltd. Şti., license number 2026/99, first license date 26.03.2026. ATC: L01EX22. Based on Sections 4.1 (Therapeutic Indications), 4.2 (Posology), and 4.5 (Interactions).
- Current drug price/reimbursement tracking sources in Türkiye (TANSTRIVE records), for SGK coverage and barcode/prescription information, as of August 2026.
- Bradford D, Larkins E, Mushti SL, et al. FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions. Clin Cancer Res. 2021.
- Solomon BJ, Tan L, Lin JJ, et al. RET solvent front mutations mediate acquired resistance to selective RET inhibition in RET-driven malignancies. J Thorac Oncol. 2020.
- Drilon A, Subbiah V, Gautschi O, et al. Selpercatinib in patients with RET fusion-positive non-small-cell lung cancer: updated safety and efficacy from the registrational LIBRETTO-001 phase I/II trial. J Clin Oncol. 2023.
Editor's note: This article provides general information only and is not medical advice, a diagnosis, or a treatment recommendation. Information compiled from FDA approval announcements, TİTCK records, and current drug price/reimbursement tracking sources was updated in August 2026. Selpercatinib was licensed by TİTCK in Türkiye on March 26, 2026, under the name TANSTRIVE; sources reviewed when this article was prepared indicate that the medicine was not covered by SGK . This may change, and readers should confirm current information directly with a pharmacist or SGK before planning treatment. Reported pack prices were compiled from third-party drug price tracking sites and could not be independently verified against an official source. Brand names differ by country: Retevmo in the United States, Retsevmo in Europe, and TANSTRIVE in Türkiye. The medicine is meaningful only for patients with confirmed RET gene alterations, requiring comprehensive genomic testing. Dose, monitoring, and treatment duration must be determined solely according to current product information and the treating oncologist's decision; this monograph provides no numerical dosing instructions for an individual patient. It does not recommend starting, stopping, or changing any medicine. Consult the physician familiar with your case for every health-related decision.
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