EMA validates filing of BMS 986016 + Opdivo for advanced melanoma.- BMS
The filing was based on the efficacy and safety results from the Phase II/III RELATIVITY-047 trial, which is the first trial 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 (ASCO) Annual Meeting in June 2021. Data were also presented in an oral presentation during the European Society for Medical Oncology (ESMO) Annual Meeting in September 2021.
The FDA has also accepted for priority review the Biologics License Application (BLA) for the relatlimab and nivolumab fixed-dose combination.
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