The U.S. Food and Drug Administration approved Eli Lilly's Inluriyo-Verzenio combination for adults with metastatic breast cancer that is estrogen receptor-positive, HER2-negative and carries an ESR1 mutation after at least one hormone treatment. In a late-stage study of 159 patients, the combination delayed cancer worsening for a median 11.1 months, compared with 5.5 months for Inluriyo alone. Lilly said about half of patients with this cancer subtype develop an ESR1 mutation during or after hormone-blocking therapy. Inluriyo is a daily pill that blocks and breaks down estrogen receptors, while twice-daily Verzenio slows cancer-cell division. Lilly said the combination is immediately available in the United States and carries risks including severe diarrhea, low white blood cell counts, lung inflammation, liver problems and blood clots. Inluriyo's label also warns of embryo-fetal toxicity during pregnancy.