NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY) said FDA has accepted for priority review the Biologics License Application for relatlimab and nivolumab fixed-dose combination in the treatment of adult and pediatric patients with unresectable or metastatic melanoma. The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial. The FDA assigned a PDUFA goal date of March 19, 2022.
Bristol Myers Squibb is currently evaluating relatlimab, LAG-3-blocking antibody, in clinical trials in combination with other agents in a variety of tumor types.
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