BMS cancer immunotherapy receives U.S. FDA approval

The immunotherapy Relatlimab will be used in combination with the company’s already approved Opdivo.



On Friday the Food and Drug Administration (FDA) approved Bristol Myers Squibb’s (BMS) cancer immunotherapy as a first line treatment for advanced melanoma in patients 12 and older. The drug which is the first of its class is expected to generate over $4 billion in annual sales. Samit Hirawat, BMS Chie Medical Officer stated, “The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.” The lymphocyte-activation gene (LAG) 3 inhibitor will be used in combination with the company’s immunotherapy Opdivo. Hirawat said, “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab (Opdivo), represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients.”


The FDA granted approval based on results from a Phase II/III study which enrolled over 700 participants. The participants in the study were randomised to either a combination treatment or Opdivo as a single therapy. Relatlimab doubles the time it takes for an advanced melanoma to worsen compared to Opdivo when administered on its own. "Our hypothesis is that the best applicability of a LAG-3 inhibitor will be in combination with a PD-1 inhibitor" like Opdivo Hirawat noted. He further added that LAG-3 inhibitors can revive the immune system by repairing the function of “exhausted” T cells. BMS expects the combination therapy to cost $27,389. Opdivo and relatlimab are being tested as a combination therapy in other cancer types such as lung, colorectal and liver cancer.