RETEVMO
Retevmo (selpercatinib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients with various cancers characterized by RET gene alterations. It is used to treat RET fusion-positive non-small cell lung cancer, medullary thyroid cancer with RET mutations, and RET fusion-positive thyroid cancer. Additionally, it is approved for patients with locally advanced or metastatic solid tumors harboring RET gene fusions that have progressed after prior systemic therapy or lack alternative options.
How RETEVMO Works
Selpercatinib functions as a kinase inhibitor that targets wild-type and multiple mutated isoforms of the RET protein. In certain cancers, RET gene fusions or point mutations create constitutively active proteins that drive tumor cell proliferation. By inhibiting these proteins, selpercatinib demonstrates anti-tumor activity across various models of RET-driven disease. The drug also inhibits other targets, including VEGFR and FGFR, at clinically achievable concentrations.
Details
- Status
- Prescription
- First Approved
- 2020-05-08
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
RETEVMO Approval History
What RETEVMO Treats
4 indicationsRETEVMO is approved for 4 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Medullary Thyroid Cancer
- Thyroid Cancer
- Solid Tumors
RETEVMO Competitors
Pro1 other drug also targets FGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (FGFR). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RETEVMO FDA Label Details
ProIndications & Usage
FDA Label (PDF)RETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test,...
RETEVMO Patents & Exclusivity
Patents (516 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.