FDA approves efficacy supplement for Eli Lilly's Retevmo (selpercatinib)

The U.S. Food and Drug Administration approved a supplemental application for Retevmo (selpercatinib), Eli Lilly and Company's oral cancer therapy, according to FDA drug approval records. The submission was filed under NDA213246 as supplement number 17, classified as an efficacy submission and reviewed under standard priority.¹

FDA marked the submission status as approved, with a submission status date of 2026-07-14.¹ The agency's approval letter is dated July 15, 2026, and an updated product label followed on July 29, 2026, based on the application documents listed in the filing.

Retevmo is marketed in two oral capsule strengths. The approved products include a 40 mg oral capsule and an 80 mg oral capsule, both containing the active ingredient selpercatinib.¹

The approval letter filename referenced in the FDA record also lists a second application, 218160Orig1s007, alongside the Retevmo supplement, suggesting the two were processed together, though the supplied documents do not specify what that second application covers or its relationship to Retevmo. The sponsor of record for the NDA213246 filing is Eli Lilly and Co.¹

The FDA record does not include details on the specific clinical indication, trial data, or efficacy results supporting this supplement. Readers seeking the underlying rationale for the label update should consult the linked FDA label document dated July 29, 2026, and the approval letter dated July 15, 2026, for further specifics not captured in the summary record.