FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
In a move that will have direct impact on approval of cancer drugs, George Francis Tidmarsh, an oncologist and a longtime pharmaceutical executive, was named director of the FDA Center for Drug Evaluation and Research.
