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# FDA Full Approval for Lilly’s Retevmo
- URL: https://www.fdaweb.com/fda-full-approval-for-lillys-retevmo/
- Published: 2024-09-27T12:00:00.000Z
- Updated: 2026-09-14T14:42:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157875

FDA has granted Eli Lilly full approval for Retevmo (selpercatinib) for adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy. The drug [received](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-lung-and-thyroid-cancers-ret-gene-mutations-or-fusions?ref=fdaweb.com) accelerated approval for the indication for patients 12 years of age and older in 2020, and earlier this year the indication was expanded to pediatric patients two years of age and older.

The approval is based on data from the LIBRETTO-531 (NCT04211337) randomized study whose main efficacy outcome measure was progression-free survival (PFS), according to an FDA news release. FDA notes that median PFS was not reached in the selpercatinib arm, but “clinical benefit of selpercatinib was supported by a pre-specified analysis of patient-reported comparative side effect impact; patients in the selpercatinib arm reported less time with severe side effect bother than those receiving cabozantinib or vandetanib.”

On the safety side, the most common adverse reactions were hypertension, edema, dry mouth, fatigue, and diarrhea, the agency says. The most common Grade 3 or 4 laboratory abnormalities (experienced by more the 5% of treated patients) were decreased lymphocytes, increased alanine aminotransferase, decreased neutrophils, increased alkaline phosphatase, increased blood creatinine, decreased calcium, and increased aspartate aminotransferase.