Bristol Myers’ new cancer immunotherapy gets FDA approval

The US Food and Drug Administration (FDA) last week announced approval of an initial treatment for advanced melanoma, the deadliest form of skin cancer.

FDA describes the approved drug, Opdualag, produced by Bristol-Myers Squibb, as “a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.”

The medicine is Bristol Myers’ third approved cancer immunotherapy, Reuters reports, with previous developments including its “blockbuster” immunotherapy Opdivo, which targets a protein called PD-1, and the CTLA-4 inhibitor Yervoy, the drugmaker’s first such drug.

“Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients,” Samit Hirawat, chief medical officer, global drug development of Bristol Myers Squibb, said in a press release. “The best applicability of a LAG-3 inhibitor will be in combination with a PD-1 inhibitor like Opdivo” because “LAG-3 inhibitors like relatlimab can reinvigorate the immune system by restoring the function of ‘exhausted’ T cells,” which could improve Opdivo’s performance.

For Opdualag’s review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), and Switzerland’s Swissmedic under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which “provides a framework for concurrent submission and review of oncology drugs among international partners.”

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