FDA Approves Kisqali (Ribociclib) for Breast Cancer

The US Food and Drug Administration (FDA) has approved the targeted drug Kisqali (ribociclib) for women with a certain type of breast cancer. It’s for treating postmenopausal women who have not already had drug treatment, and whose cancer is hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative, and advanced or metastatic (has spread to other parts of the body). Kisqali is meant to be taken along with the hormone therapy drug letrozole.

Kisqali works by blocking 2 proteins called cyclin-dependent kinases (CDKs) that help cancer cells grow. It was approved under the FDA’s breakthrough therapy and priority review programs designed to speed up the availability of drugs that show promise against a serious disease.

The FDA based its approval on results from a clinical trial called MONALEESA-2 that involved 668 women. The trial showed that Kisqali and letrozole reduced the risk of death or of the cancer getting worse by 44% compared to letrozole alone.

Both Kisqali and letrozole are pills taken by mouth once a day. The most common side effects of Kisqali are low white blood cell counts, nausea and vomiting, fatigue, diarrhea, constipation, hair loss, headache, and back pain. More serious, but less common side effects can include heart and liver problems.

Kisqali is marketed by Novartis.

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