Selpercatinib
Approved · FDA / EMAAlso known as Retevmo.
Recent clinical, regulatory, research and industry developments relating to this drug.
Indication expansion: SELPERCATINIB (NDA213246)
Indication expansion: SELPERCATINIB (NDA218160)
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
Neoadjuvant Treatment With Selpercatinib in RET-Altered Thyroid Cancers
Indication expansion: SELPERCATINIB (NDA213246)
Indication expansion: SELPERCATINIB (NDA218160)
Efficacy of Selpercatinib in <i>RET</i>-Altered Thyroid Cancers.
Efficacy of Selpercatinib in <i>RET</i> Fusion-Positive Non-Small-Cell Lung Cancer.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET… Show full indicationShow less
Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. For biomarker-based patient selection, see section 4.2. Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . For biomarker-based patient selection, see section 4.2. advanced RET mutant medullary thyroid cancer (MTC) . For biomarker-based patient selection, see section 4.2. advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Journals, researchers & institutions
- The New England journal of medicine2
- Barlesi F2
- Drilon A2
- Ebata K2
- Gautschi O2
- Huang X2
- Nguyen M2
- Patel J2
- Rothenberg SM2
- From Massachusetts General Hospital (L.J.W.) and Dana-Farber Cancer Institute (J. Lorch)1
- From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College (A.D.1
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.