USFDA approves Novartis' Kisqali for early-stage breast cancer treatment

In a significant development for breast cancer treatment, Novartis has announced that the US Food and Drug Administration (FDA) has approved Kisqali (ribociclib) for use in combination with hormone therapy for certain early-stage breast cancer patients. This approval marks a breakthrough for individuals diagnosed with hormone receptor-positive (HR+)/HER2-negative stage II and III early breast cancer, including those without lymph node involvement. The FDA’s decision is based on promising results from clinical trials that demonstrated Kisqali’s effectiveness in significantly reducing the risk of cancer recurrence when used alongside hormone therapy.

This is particularly vital for early-stage breast cancer patients, who face an ongoing concern about the possibility of cancer returning. Kisqali is administered as an oral pill, taken daily for three weeks, followed by a one-week break, over a course of three years. The treatment has shown a manageable safety profile, with some of the more common side effects being a low white blood cell count and liver-related issues.



.