FDA real-time pilot speeds Kisqali label expansion

FDA announced on Wednesday that it approved Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN) in combination with an aromatase inhibitor for breast cancer in premenopausal and perimenopausal women in the first-line setting, five months ahead of the PDUFA goal, based on a review that took less than three weeks.

The approval is the first made through FDA's Real-Time Oncology Review, which allows the agency to begin reviewing an application before it is submitted. Kisqali also received approval Wednesday through the pilot program for the indication in combination with Faslodex fulvestrant as first- or second-line therapy in postmenopausal women...