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March 13, 2017

Novartis has gained the FDA approval for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor. Also known as ribociclib, the drug hits the market as Kisqali with peak sales estimates of approximately $2.5 billion a year. This gives the pharma giant a clear shot at a new blockbuster franchise.

This approval puts Novartis in direct competition with Pfizer’s Ibrance (palbociclib), the pioneer in this field. Eli Lilly is also coming up from behind with abemaciclib.

Bruno Strigini, CEO, Novartis Oncology, said: “Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer. We at Novartis are proud of the comprehensive clinical program for Kisqali that has led to today’s approval and the new hope this medicine represents for patients and their families.”

“Combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer,” noted Gabriel N. Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, The University of Texas, MD Anderson Cancer Center and MONALEESA-2 Principal Investigator.

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