BMS’s sBLA accepted by the FDA

The US Food and Drug Administration has recently accepted Bristol-Myers Squibb Company’s (BMS) supplemental Biologics License Application (sBLA), granting priority review for Opdivo (nivolumab) in combination with Yervoy (ipilimumab), to treat recurrent or metastatic non-small cell lung cancer (NSCLC) with no ALK or EGFR mutations. The decision was based off of data from Part one of the Phase three CheckMate two-two-seven trial, which revealed that the combination demonstrated a larger improvement in overall survival versus chemotherapy.

BMS’s development lead for thoracic cancers, Sabine Maier, M.D., stated “The FDA’s acceptance of our application for Opdivo plus Yervoy represents an important milestone for patients with lung cancer in the United States where despite recent treatment advances, lung cancer remains the cause of more than one-hundred and fifty thousand deaths each year. Lung cancer is the 3rd tumour type where the combination of Opdivo and Yervoy has demonstrated significant long term overall survival benefit in a randomized Phase three trial, which further validates the immunologic rationale for dual Immuno-Oncology therapy.”