The FDA has as granted full approval to Eli Lilly’s Inluriyo, an oral selective estrogen receptor degrader (SERD), in combination with the company’s CDK4/6 inhibitor.
The combo is approved 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.
"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 —I s 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.
This marks the second FDA approval for Inluriyo in less than a year, following its September 2025 approval as monotherapy for the treatment of adults with ER+, HER2–, ESR1-mutated MBC whose disease progressed after at least one line of endocrine therapy