FDA awards Novartis expanded approval for breast cancer therapy

Kisqali, a key targeted therapy for breast cancer from Novartis, until now has been indicated only for patients with metastatic disease. But on Tuesday, the Food and Drug Administration approved Kisqali in combination with hormone therapy for patients with certain early-stage breast cancers, significantly expanding the number of patients that will have access to this type of drug.

“It includes the entire stage 3 and 70% of stage 2. That’s two times the size of what other CDK4/6 inhibitors are approved for,” said Victor Bulto, president of the Novartis United States unit.”

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