FDA accepts relatlimab and nivolumab fixed-dose for priority review in melanoma

The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) submitted by US pharma major Bristol Myers Squibb (NYSE: BMY) for the LAG-3-blocking antibody relatlimab and Opdivo (nivolumab) fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb.