US FDA clears Lilly's Inluriyo-Verzenio combo for advanced breast cancer

The US Food and Drug Administration has approved a two-drug combination from Eli Lilly for adults with a form of advanced breast cancer that has spread to other parts of the body, the company said on Friday.

The regimen pairs Inluriyo with Verzenio and is intended for patients whose tumours are estrogen receptor-positive, HER2-negative and carry an ESR1 mutation, and whose disease has worsened after at least one round of hormone treatment.

According to Lilly, roughly half of patients with ER-positive, HER2-negative metastatic breast cancer go on to develop an ESR1 mutation during or after treatment with a widely used class of hormone-blocking therapies.

The FDA had previously cleared Inluriyo in September last year for metastatic breast cancer, also known as Stage IV breast cancer, with ESR1 mutations.

The latest approval rests on a late-stage trial of 159 patients with this type of advanced disease. Those who received both drugs went a median of 11.1 months before their cancer worsened, compared with 5.5 months for patients who took Inluriyo alone.

HR+/HER2- is the most common subtype of breast cancer, which is the second leading cause of cancer death among women.

Inluriyo is a once-daily pill that blocks and breaks down estrogen receptors that can help some breast cancers grow, while Verzenio is taken twice a day and works by slowing the division of cancer cells.

The combination carries risks, the company said, 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, referring to the potential for harm to a developing embryo or fetus if exposure occurs during pregnancy.

Lilly said the Inluriyo plus Verzenio regimen is available immediately in the United States.