U.S. FDA approves Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

Inluriyo plus Verzenio delivers proven clinical benefit after the evidence-based practice of maximizing initial treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor In the Phase 3 EMBER-3 trial, Inluriyo in combination with Verzenio doubled median progression-free survival compared to Inluriyo alone, among patients with ESR1 -mutated MBC The all-oral combination of Inluriyo and Verzenio gives patients a treatment approach that targets the two central drivers of ER+ breast cancer, with an established tolerability profile and no new monitoring required INDIANAPOLIS , Sept. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1- mutated locally advanced or metastatic breast cancer (MBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. The approval is based on the proven clinical benefit of switching to Inluriyo in combination with Verzenio at clinical progression as observed in the Phase 3 EMBER-3 trial. "In less than a year since its approval, Inluriyo is the leading treatment option for people with ER+, HER2–, ESR1 m metastatic breast cancer, now reaching over half of all patients starting an oral SERD," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Today's full approval extends what Inluriyo in combination with Verzenio can do for patients, with a regimen that has confirmed benefit, is aligned to the clinically proven treatment paradigm of changing therapy at clinical progression, and doesn't introduce burdensome monitoring requirements for patients or physicians. In fact, all available evidence suggests that switching endocrine therapy and CDK4/6 inhibitor at clinical progression improves patient outcomes more than switching therapy earlier. Utilizing this evidence-based practice spares early exposure to additional side effects, reduces patient anxiety from unnecessary testing, and mitigates avoidable costs to the healthcare system." This full FDA approval is based on the results of the Phase 3 EMBER-3 trial in patients with MBC whose tumors harbor an ESR1 mutation (n=159). Patients received Inluriyo (n=92) or Inluriyo in combination with Verzenio (n=67) after an aromatase inhibitor (AI), with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. Among patients with ESR1 -mutated MBC, Inluriyo in combination with Verzenio doubled median progression-free survival (PFS) versus Inluriyo alone, with a median PFS of 11.1 months versus 5.5 months (HR=0.53 [95% CI, 0.35–0.80]). "We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy. Combining therapies that work on two distinct drivers of tumor growth—the estrogen receptor and CDK4/6—is an important strategy to help address treatment resistance," said Komal Jhaveri, MD, FACP, FASCO, Associate Attending Breast Medicine and Early Drug Development Services, section head of the Endocrine Therapy Research Program at Memorial Sloan Kettering Cancer Center , and principal investigator for the EMBER-3 and EMBER-4 trials. "In EMBER-3, switching both the endocrine therapy and CDK 4/6 inhibitor, for the majority of patients, to imlunestrant plus abemaciclib at disease progression achieved a median progression-free survival of 11.1 months and a safety profile consistent with that of each medicine individually, establishing a meaningful new treatment option." In about half of patients with ER+, HER2– MBC, tumors develop a genetic change called an ESR1 mutation during or after treatment with a common class of hormone.