Ribociclib regulatory update

FDA accepted and granted Priority Review to an NDA from Novartis for ribociclib as first-line treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with letrozole. Novartis declined to disclose the PDUFA date. The pharma 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. The NDA was based on data from the Phase III MONALEESA-2 trial (see BioCentury, Oct. 17, 2016)...