FDA clears new efficacy supplement for Novartis's Kisqali
The agency approved supplement 27 to Kisqali's application under priority review, with a label update dated July 10, 2026.
The FDA has approved a new efficacy supplement to the application for Kisqali (ribociclib succinate), made by Novartis. The submission was filed under application number NDA209092, reviewed under priority review, and given submission number 27.1
The submission status is listed as approved, with a status date of July 1, 2026.1 Kisqali is supplied as an oral tablet, with the active ingredient ribociclib succinate at a strength equivalent to 200 mg base.1
Two application documents were filed alongside the approval: a letter dated July 6, 2026, and an updated product label dated July 10, 2026.1
The source record does not specify the indication or patient population covered by this supplement, nor does it detail the clinical data or endpoints that supported the efficacy submission. No further information on dosing changes, trial results, or the nature of the efficacy claim under review was included in the documentation provided.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.