Novartis’s blockbuster CDK 4/6 contender LEE011 gets a VIP countdown at the FDA
Novartis’s LEE011 (ribociclib) is getting VIP treatment at the FDA. A few weeks after posting impressive late-stage data for its CDK 4/6 drug, the agency has given it a priority review schedule, lopping four months off the usual regulatory review.
Novartis adds that the EMA has also accepted their application for first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with letrozole.
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