Bristol Myers Wins FDA Review of Mezigdomide in Multiple Myeloma

 Bristol Myers Squibb said the U.S. Food and Drug Administration has accepted its application seeking approval of its proposed cancer drug mezigdomide in certain patients with the blood cancer multiple myeloma.

Bristol Myers on Monday said the application covers mezigdomide in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma.

The Princeton, N.J., drugmaker said the FDA has assigned a target action date of May 13, 2027, for a decision.

Mezigdomide is part of a new class of medicines called cereblon E3 ligase modulator, or CELMoD, agents, which work by binding to cereblon, a protein found in the body's natural waste-disposal system. The drugs then trigger the degradation of cancer-driving proteins, thus killing the cancer cells themselves.

Another Bristol Myers CELMoD agent, iberdomide, is under FDA review for multiple myeloma, with a target action date of Aug. 17. A green light would make iberdomide the first FDA-approved CELMoD agent.

https://www.morningstar.com/news/dow-jones/202607132969/bristol-myers-wins-fda-review-of-mezigdomide-in-multiple-myeloma