Merck's KEYTRUDA Plus Padcev Wins CHMP Backing for EU Bladder Cancer

Eli Lilly and Company announced that the U.S. Food and Drug Administration has granted full approval to Inluriyo, or imlunestrant, in combination with Verzenio, or abemaciclib, for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The decision rests on the Phase 3 EMBER-3 trial, in which the combination doubled median progression-free survival versus Inluriyo alone, at 11.1 months versus 5.5 months, with a hazard ratio of 0.53 and a 95% confidence interval of 0.35 to 0.80, among the 159 patients with ESR1-mutated metastatic breast cancer. In that trial, 92 patients received Inluriyo alone and 67 received the combination after an aromatase inhibitor, with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. The approval marks the second FDA clearance for Inluriyo in less than a year, following its September 2025 monotherapy approval for the same ER-positive, HER2-negative, ESR1-mutated metastatic population. Inluriyo is also being studied in the Phase 3 EMBER-4 trial in the adjuvant setting for ER-positive, HER2-negative early-stage breast cancer, the largest adjuvant oral SERD trial with more than 8,000 patients enrolled across 650-plus sites in more than 30 countries, with initial results anticipated in 2027. The combination is now available in the United States.