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Priority Review for Novartis' ribociclib

November 1, 2016 11:21 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted and granted Priority Review to an NDA for ribociclib (LEE011) as a first-line treatment for postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer in combination with letrozole. Novartis spokesperson Dana Cooper declined to give its PDUFA date. Novartis also said EMA accepted for review an MAA for the ribociclib combination to treat the same indication.

The cyclin dependent kinase 4 (CDK4) and CDK6 inhibitor has breakthrough therapy designation in the U.S. Novartis based the NDA on data from the Phase III MONALEESA-2 trial (see BioCentury Extra, Oct. 10)...