Five PDUFA dates on FDA’s October agenda

FDA has at least five PDUFA dates in October, including therapies for two rare diseases and label expansions for Opdivo and a Lumakras combination. 

Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY) is under review for neoadjuvant therapy followed by perioperative adjuvant treatment of resectable stage IIA to IIIB non-small cell lung cancer. The sBLA is based on data from Phase III CheckMate -77T trial, which evaluated Opdivo with chemotherapy before surgery and as adjuvant therapy after. The PD-1 inhibitor led to a 42% (p=0.00025) reduction in disease recurrence, progression or death versus neoadjuvant chemotherapy followed by surgery, and increased rates of pathological complete response and major pathologic response. ...