FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma

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

The FDA has granted priority review of the Biologics License Application (BLA) for the combination of relatlimab and Opdivo (nivolumab), administered as a single infusion, for the treatment of adult and adolescents with unresectable or 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 2/3 RELATIVITY-047 trial, which demonstrated that the combination therapy achieved progression-free survival benefit of 10.1 months compared with 4.6 months for Opdivo alone.

“We believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma,” Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb, said in a statement.

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 during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021. Adverse events leading to discontinuation of treatment in 14.6% of patient receiving the combination therapy versus 6.7% for those receiving Opdivo alone.

Lymphocyte-activation gene 3 (LAG-3) functions to control T-cell response, activation, and growth.

Melanoma is the fifth most common cancer, according to the National Institutes of Health. The NIH estimates that in 2021 more than 7,000 people will die from melanoma.