FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer
CONFIRMED85% CONFIDENCELilly's release is datelined "INDIANAPOLIS, Sept. 18, 2026" and says it "announced today that the U.S. Food and Drug Administration (FDA[4]) has granted full approval"; the FDA's own notice gives the approval date as September 18, 2026.
An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.
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