+ Regulatory
Gene Johnson | Mar 24, 2017

FDA approves new drug for the treatment of advanced breast cancer in women

The Food and Drug Administration (FDA) has approved Novartis' Kisqali to be used in treating metastatic or advanced breast cancer in women. 

"Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer," Bruno Strigini, CEO of Novartis oncology, said in a press release. "We at Novartis are proud of the comprehensive clinical program for Kisqali that has led to approval and the new hope this medicine represents for patients and their families."

The drug, used in conjunction with letrozole, was shown to provide a 44 percent reduction in the risk of disease progression and death over letrozole alone, according to the press release. 

Kisqali was reviewed and approved under the FDA's breakthrough therapy designation and priority review programs. 

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