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 spread after hormone therapy. Results from a trial show that among 159 participants with ESR1 mutations, those taking the combination went a median of 11.1 months before their cancer spread, or they died, compared with 5.5 months for those taking Inluriyo alone. A blood test can show whether breast cancer has an ESR1 mutation, according to the FDA. People with advanced breast cancer that has spread despite hormone therapy, and with tumors that carry a gene change called an ESR1 mutation, have a new treatment option. The Food and Drug Administration (FDA) approved the use of an all-oral combo pill on September 18: Inluriyo (imlunestrant) and Verzenio (abemaciclib), both manufactured by Eli Lilly and Company. Inluriyo blocks estrogen’s signal in certain breast cancer cells and helps break down th…

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