FDA Approves Eli Lilly Inluriyo (Imlunestrant, Oral SERD) + Verzenio (Abemaciclib, CDK4/6 Inhibitor) Combination for ER+/HER2−/ESR1-Mutated Advanced or Metastatic Breast Cancer After Prior Endocrine Therapy; Median PFS 11.1 Months vs 5.5 Months on Monotherapy
The FDA approved Friday September 18, 2026 Eli Lilly's (NYSE: LLY) Inluriyo (imlunestrant, oral next-generation selective estrogen receptor degrader / SERD) in combination with Verzenio (abemaciclib, oral CDK4/6 inhibitor) for adults with estrogen-receptor-positive (ER+), HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one prior line of endocrine therapy. ESR1 mutations are detected via the FDA-authorized Guardant360 CDx companion diagnostic (Guardant Health, NASDAQ: GH). Patients on the combination had median progression-free survival of 11.1 months versus 5.5 months on Inluriyo monotherapy — an approximately 2× improvement. This is Inluriyo's second FDA approval within a year after its September 2025 monotherapy approval in the same population and is the first FDA-approved oral-SERD + CDK4/6 inhibitor combination in this setting. The approval strengthens Lilly's breast-cancer franchise anchored by Verzenio ($6.3B 2025 global sales) and expands the addressable population for both agents.