FDA approves supplement 7 for Eli Lilly's Retevmo (selpercatinib)
The agency cleared an efficacy-related labeling update for the RET inhibitor, with a new label dated July 29, 2026.
The FDA approved supplement 7 to Eli Lilly's New Drug Application for Retevmo (selpercatinib), an oral RET inhibitor. The submission was classified as an efficacy supplement, and the application's status was updated to approved (AP) with a submission status date of 2026-07-14.1
The approval covers Retevmo across its existing dosage forms. The product line includes 40 mg and 80 mg capsules as well as 40 mg, 80 mg, 120 mg, and 160 mg tablets, all administered orally.1
Two application documents accompany this action. An approval letter dated July 15, 2026 was issued jointly under application numbers 213246 (original s017) and 218160 (original s007), and a revised product label was posted on July 29, 2026.1
The review was processed under standard, rather than priority, review timelines. FDA classified the review priority for this submission as standard.1 Eli Lilly and Co. is listed as the sponsor for the application.
No additional details on the specific clinical data or labeling changes driving this efficacy supplement were included in the available records. Readers interested in the substance of the labeling revision should consult the July 29, 2026 label document directly for the updated indications, dosing information, or safety language associated with this approval.
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