US FDA approves Lilly's breast cancer drug combo

Sept. 18 (Reuters) - The US FDA has approved Eli Lilly's LLY.N drug combination to treat adults with a type of advanced breast cancer that has spread to other parts of the body, the drugmaker said on Friday.

Here are some details:

• The combination, Inluriyo-Verzenio, is meant for patients whose tumors are estrogen receptor-positive, HER2-negative and carry an ESR1 mutation, and whose cancer has worsened after at least one hormone treatment.
• About half of the patients with ER-positive, HER2-negative metastatic breast cancer develop an ESR1 mutation during or after treatment with a widely used class of hormone-blocking therapies, Lilly said.
• The US Food and Drug Administration had approved Inluriyo in September last year to treat metastatic breast cancer, also called Stage IV breast cancer with ESR1 mutations.
• The approval was based on a late-stage study of 159 patients with this type of advanced breast cancer. Patients who took both drugs went a median of 11.1 months before their cancer worsened, compared with 5.5 months for those who took Inluriyo alone.
• HR+/HER2- is the most common subtype of breast cancer — the second leading cause of cancer death in women.
• Inluriyo is a daily pill that blocks and breaks down estrogen receptors that can help some breast cancers grow, while Verzenio is a twice-daily pill that slows cancer-cell division.
• The combination also carries risks, Lilly said, including severe diarrhea, low white blood cell counts, lung inflammation, liver problems and blood clots.
• Inluriyo's label includes a warning for embryo-fetal toxicity, which refers to potential risk of harm to a developing embryo and fetus if exposure occurs during pregnancy.
• Lilly said Inluriyo plus Verzenio is available immediately in the United States.