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Retevmo (SELPERCATINIB)
Retevmo works by blocking the activity of the RET protein, which is involved in the growth and spread of cancer cells.
Retevmo (selpercatinib) is a small molecule kinase inhibitor developed by LOXO ONCOLOGY INC and currently owned by Eli Lilly And Co. It targets the proto-oncogene tyrosine-protein kinase receptor Ret, a protein involved in the growth and spread of certain types of cancer. Retevmo is approved to treat advanced RET fusion-positive non-small cell lung cancer, advanced RET fusion-positive thyroid cancer, medullary thyroid carcinoma, and metastatic non-small cell lung cancer. The drug has a half-life of 32 hours and is patented, with no generic manufacturers available. Key safety considerations include potential liver damage and gastrointestinal side effects.
At a glance
| Generic name | SELPERCATINIB |
|---|---|
| Sponsor | Eli Lilly |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Proto-oncogene tyrosine-protein kinase receptor Ret |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 700 |
Mechanism of action
Selpercatinib is kinase inhibitor. Selpercatinib inhibited wild-type RET and multiple mutated RET isoforms as well as VEGFR1 and VEGFR3 with IC50 values ranging from 0.92 nM to 67.8 nM. In other enzyme assays, selpercatinib also inhibited FGFR 1, 2, and at higher concentrations that were still clinically achievable. In cellular assays, selpercatinib inhibited RET at approximately 60-fold lower concentrations than FGFR1 and and approximately 8-fold lower concentration than VEGFR3.Certain point mutations in RET or chromosomal rearrangements involving in-frame fusions of RET with various partners can result in constitutively activated chimeric RET fusion proteins that can act as oncogenic drivers by promoting cell proliferation of tumor cell lines. In in vitro and in vivo tumor models, selpercatinib demonstrated anti-tumor activity in cells harboring constitutive activation of RET proteins resulting from gene fusions and mutations, including CCDC6-RET, KIF5B-RET,
Approved indications
- Advanced RET fusion-positive non-small cell lung cancer
- Advanced RET fusion-positive thyroid cancer
- Medullary thyroid carcinoma
- Metastasis from malignant tumor of thyroid
- Metastatic non-small cell lung cancer
Common side effects
- Diarrhea
- Constipation
- Fatigue
- Edema
- Hypertension
- Rash
- Headache
- Cough
- Dyspnea
- Dry Mouth
- Nausea
- Vomiting
Key clinical trials
- Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
- Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) (PHASE2)
- A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (PHASE3)
- A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (PHASE3)
- Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (PHASE2)
- Feasibility Study for Repurposing RET Inhibitors (EARLY_PHASE1)
- A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Retevmo CI brief — competitive landscape report
- Retevmo updates RSS · CI watch RSS
- Eli Lilly portfolio CI