Bristol Myers Squibb (NYSE: BMY) has won priority review for its Biologics License Application for the fixed-dose combination of the checkpoint inhibitors relatlimab and nivolumab to treat patients 12 and older who weigh at least 40 kg (88 pounds) with unresectable or metastatic melanoma.
Relatlimab would be a novel lymphocyte-activation gene 3 (LAG-3) blocking antibody. The drug would be the third distinct checkpoint inhibitor from Princeton, New Jersey–based Bristol Myers Squibb to help appropriate patients.
Nivolumab, whose brand name is Opdivo, generated $6.9 billion in sales last year. The drug came in at slot 10 in our list of best-selling pharmaceuticals in 2020. Nivolumab targets programmed cell death protein 1 (PD-1).
“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there remain patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, Bristol Myers Squibb’s senior vice president and head of oncology department, in a statement.
“Based on the results of the RELATIVITY-047 trial, we believe that the fixed-dose combination of relatlimab and nivolumab has the potential to improve the future of treatment for certain patients with metastatic or unresectable melanoma.”
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.
In March, BMS announced that the RELATIVITY-047 trial met its primary endpoint of progression-free survival.
BMS based the application on its Phase 2/3 trial that found that the combination therapy led to a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy compared to standard of care anti-PD-1 monotherapy in metastatic melanoma.
BMS and its partner Ono Pharmaceuticals have included relatlimab in 40 clinical trials to date. Both companies have partnered on several immunotherapies with BMS having global rights to commercialize Opdivo in regions outside of Japan, South Korean and Taiwan.