FDA Approves Lilly’s New Oral Combo Pill for Common Breast Cancer Mutation
The Eli Lilly corporate headquarters in Indianapolis, IN, on August 15, 2024. AJ Mast/Bloomberg via Getty Images The FDA approved a new oral combo drug for a common breast cancer mutation on September 18. The treatment includes Inluriyo (imlunestrant) taken with Verzenio (abemaciclib) for adults with ER-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutation that has…
On September 18, 2024, the Food and Drug Administration (FDA) approved a new oral combination drug from Eli Lilly for adults with advanced or metastatic breast cancer carrying an ESR1 mutation. The treatment combines Inluriyo (imlunestrant) and Verzenio (abemaciclib), both manufactured by Eli Lilly.
The drug targets specifically those individuals whose breast cancer has spread despite hormone therapy and has an ESR1 mutation. Results from the clinical trial, named EMBER-3, show that patients taking the combination had a median time of 11.1 months before their cancer spread or they passed away, compared to 5.5 months for those taking Inluriyo alone.
Tumor shrinkage was observed in 35% of participants on the combination, versus 15% on Inluriyo alone, although survival data was not yet available as the trial was not powered to assess this outcome.
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