FDA accepts BMS 986016 + Opdivo for priority review in metastatic melanoma.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.
The BLA submission was based on the efficacy and safety results of the Phase II/III 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 III 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.
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