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FDA Accepts Priority Review for Melanoma Treatment


Bristol Myers Squibb has announced that the FDA has accepted the Biologics License Application (BLA) for relatlimab and nivolumab, a fixed-dose combination treatment for unresectable or metastatic melanoma.

Bristol Myers Squibb has announced today that the FDA accepted the priority review for the Biologics License Application (BLA) for the fixed combination dose of relatlimab (Bristal Myers Squibb) and nivolumab (Bristol Myers Squibb)—lymphocyte-activation gene (LAG)-3 blockers—administered as a single infusion, for the treatment of patients 12 years or older and weighting at least 40kg diagnosed with unresectable or metastatic melanoma. The Prescription Drug User Fee Act (PDUFA) date is set for March 19, 2022.1

“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, Princeton, New Jersey.

The BLA was supported by the efficacy and safety data results of the Phase 2/3 RELATIVITY-047 (NCT03470922) trial, which has demonstrated a statically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma, according to the press release. Reportedly, relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with Phase 3 data.

The primary results from the trial were presented at the American Society of Clinical Oncology (ASCO) annual meeting in June of 2021. The fixed-dose combination of relatlimab and nivolumab is not approved for use and is still an investigational therapy. 

Chang said, “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.”


1. U. S. Food and drug administration accepts for priority review Bristol Myers Squibb’s application for lag-3-blocking antibody relatlimab and nivolumab fixed-dose combination as treatment for patients with unresectable or metastatic melanoma. Accessed September 21, 2021. https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-LAG-3-Blocking-Antibody-Relatlimab-and-Nivolumab-Fixed-Dose-Combination-as-Treatment-for-Patients-with-Unresectable-or-Metastatic-Melanoma/default.aspx

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