The European Medicines Agency validated the Marketing Authorization Application of the fixed-dose combination of Opdivo (nivolumab) and relatlimab, a LAG-3-blocking antibody, for first-line treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with advanced, unresectable or metastatic melanoma.
Both drugs are sponsored by Bristol Myers Squibb.
This application was based on the phase II/III RELATIVITY-047 trial, the first to demonstrate 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.
Primary results from the RELATIVITY-047 trial were presented in an oral abstract session and selected for the official press program for the American Society of Clinical Oncology annual meeting in June 2021. Data were also presented in an oral presentation during the European Society for Medical Oncology annual meeting in September 2021.
The EMA’s validation confirms completion of the submission and begins the centralized review process. The FDA has also accepted for priority review the Biologics License Application for the relatlimab and Opdivo fixed-dose combination.
This is an investigational therapy and is not approved for use in any country.
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