US approves Lilly's Inluriyo-Verzenio combination for advanced breast cancer

The US Food and Drug Administration has approved a combination of two Eli Lilly (LLY) pills for adults with a form of advanced breast cancer that has spread to other parts of the body, the drugmaker announced.

The regimen, Inluriyo plus Verzenio, is intended for patients whose tumors are estrogen receptor-positive, HER2-negative and carry an ESR1 mutation, and whose disease has worsened after at least one hormone therapy. Lilly said about half of patients with ER-positive, HER2-negative metastatic breast cancer develop the mutation during or after treatment with a widely used class of hormone-blocking drugs. The subtype is the most common form of breast cancer, itself the second leading cause of cancer death in women.

The FDA approved Inluriyo as a standalone treatment for metastatic, or stage four, breast cancer with ESR1 mutations in September last year. The latest decision rests on a late-stage study of 159 patients. Those who took both drugs went a median of 11.1 months before their cancer progressed, compared with 5.5 months for those given Inluriyo alone.

Inluriyo is a daily pill that blocks and degrades estrogen receptors, which can help drive some breast cancers. Verzenio, taken twice daily, slows the division of cancer cells.

Lilly said the combination carries risks including severe diarrhea, low white blood cell counts, lung inflammation, liver problems and blood clots. Inluriyo's label also includes a warning for embryo-fetal toxicity, meaning possible harm to a developing embryo or fetus if exposure occurs during pregnancy.

The combination is available immediately in the US, the company said.