FDA approves new Bristol Myers cancer immunotherapy

FDA approves new Bristol Myers cancer immunotherapy

– Bristol Myers Squibb Co said on Friday that US regulators have approved the first drug in a new class of cancer immunotherapy as the initial treatment for advanced melanoma, the deadliest form of skin cancer.

The company said it expects the drug’s annual sales to eventually top $4 billion.

The U.S. Food and Drug Administration has approved relatlimab, from a class known as LAG-3 (short for lymphocyte activation gene 3) inhibitors, for use in combination with Opdivo’s blockbuster immunotherapy as an initial treatment for advanced melanoma.

Relatlimab, which will be sold under the brand name Opdualag, more than doubles the time it takes for progressive melanoma to progress compared to Opdivo alone in clinical trials, a measure known as progression-free survival.

The drug is Bristol Myers’ third-approved cancer immunotherapy, drugs that use the body’s defenses to fight tumors. Opdivo targets a protein called PD-1. Yervoy, the drugmaker’s first such drug, is a CTLA-4 inhibitor.

Relatlimab will only be used in combination with Opdivo, Chief Medical Officer Samit Hiravat said in an interview.

Hiravat said that LAG-3 inhibitors, such as relatlimab, can boost the immune system by restoring the function of “depleted” T cells – a key component of the immune system – which could improve Opdivo’s performance.

“Our hypothesis is that the best applicability of a LAG-3 inhibitor would be in combination with a PD-1 inhibitor,” he said.

The company expects to charge $27,389 per combination.

Bristol Myers said it expects combination therapy sales to exceed $4 billion a year by 2029.

Bristol Myers is testing the combination of Opdivo and relatlimab in other tumor types, including colorectal, lung and kidney cancers.

(Reporting by Michael Erman; additional reporting by Akriti Sharma in Bangalore; editing by Bill Burcroth and Leslie Adler)