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Lilly wins additional US FDA approval for Verzenio in advanced breast cancer

Eli Lilly and Co.'s cancer medicine Verzenio won U.S. Food and Drug Administration approval for treating a type of advanced breast cancer, the third approved use for the drug within five months.

The U.S. drugmaker can market Verzenio for use with a hormone therapy known as an aromatase inhibitor in post-menopausal women with hormone-receptor positive breast cancer, which is fueled by the female hormones estrogen and progesterone. In addition, the cancer should test negative for another protein that can drive cancer, human epidermal growth factor receptor 2, which is the target of another class of medicines.

Aromatase inhibitors are older drugs used to slow or halt the growth of hormone-receptor positive tumors.

Verzenio belongs to a class of medicines known as cyclin-dependent kinase, or CDK, inhibitors, which work by blocking the action of CDK proteins that promote cancer growth. Specifically, Verzenio targets the CDK 4 and 6 proteins. The FDA approval is based on data from the clinical trial dubbed Monarch 3, which showed that the drug improved survival and stopped the disease spreading when added to endocrine therapy, compared with just treating patients with endocrine therapy alone.

The recommended dose of Verzenio in combination with an aromatase inhibitor is 150 milligrams orally twice daily, continued until the disease gets worse or patients experience a significant level of side effects, Lilly said in a Feb. 26 statement.

Verzenio is also approved in the U.S. in combination with fulvestrant, sold as Faslodex by AstraZeneca PLC, and as a single treatment for breast cancer that has progressed or spread to other sites in the body. It may also be marketed as a single therapy for patients whose breast cancer has worsened following endocrine therapy and prior chemotherapy after spreading beyond the breast tissue.

The labeling for Verzenio contains warnings and precautions for diarrhea, a low level of certain white blood cells known as neutropenia, liver toxicity, blood clots and potential harm to an embryo or fetus.