FDA approves Bristol Myers' immunotherapy for advanced melanoma

The FDA has approved Bristol Myers Squibb's Opdualag, a combination immunotherapy for the treatment of unresectable or metastatic melanoma, the drugmaker said March 18. 

Opdualag is a fixed-dose combination of nivolumab and relatimab and is administered as a single intravenous infusion. It's approved for the treatment of unresectable or metastatic melanoma in patients ages 12 and older. 

The approval is based on trial results that showed the immunotherapy treatment doubled median progression-free survival compared to nivolumab alone, an established standard of care for advanced melanoma.

"Since the approval for the first immune checkpoint inhibitor more than 10 years ago, we've seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma," said F. Stephen Hodi, MD, director of the melanoma center and center for immuno-oncology at Dana-Farber Cancer Institute in Boston. "Today's approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1."

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