Eli Lilly Receives the US FDA’s Approval for Retevmo (Selpercatinib) to Treat Thyroid Cancer or Solid Tumors
Shots:
- The US FDA has granted accelerated approval to Retevmo for pediatric population (≥2yrs.) with advanced/metastatic medullary thyroid cancer (MTC) with RET-mutation & advanced/metastatic thyroid cancer or solid tumors with a RET gene fusion
- The approval was based on P-I/II (LIBRETTO-121) study assessing the safety & efficacy of selpercatinib (92mg/m^2, oral, BID) in patients (n=25, 2-20yrs.) with locally advanced/metastatic RET-activated solid tumors unresponsive to existing treatment or without any curative therapy
- The study showed 48% cORR & mDoR not achieved with 92% responders still in response at 12mos. In pediatric & young adult patients, ORR was 43% for RET-mutant MTC (n=14) & 60% for RET fusion+ thyroid cancer (n=10)
Ref: US FDA | Image: Eli Lilly
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.