The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination demonstrated a statistically significant and clinically meaningful progression-free survival benefit over Opdivo monotherapy
U.S. Food and Drug Administration assigns a target action date of March 19, 2022
PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and 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. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma. We look forward to potentially introducing the first LAG-3-blocking antibody, and Bristol Myers Squibb’s third distinct checkpoint inhibitor, to help patients in need.”
The BLA submission was based on the efficacy and safety results of the Phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma. Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with Phase 3 data. Primary results from the RELATIVITY-047 trial were presented in an oral session during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021 and were selected for the official ASCO press program.
The fixed-dose combination of relatlimab and nivolumab is an investigational therapy and is not approved for use in any country.
Bristol Myers Squibb thanks the patients and investigators involved in the RELATIVITY-047 clinical trial.
