The U.S.
Food and Drug Administration (FDA) on Thursday granted accelerated approval to Bristol Myers Squibb & Co.'s (NYSE:BMY) Zenbexus (iberdomide) for adult patients with multiple myeloma.
The approval is for use in combination with daratumumab, hyaluronidase-fihj, and dexamethasone (ZDd) for patients who have undergone at least one prior therapy line, including a proteasome inhibitor and an immunomodulatory agent.
This makes Zenbexus the first FDA-approved CELMoD, a novel class of cereblon-modulating protein degraders.
Read Also: AstraZeneca-Bristol Myers Merger Buzz Puts Patent Expiration and Deal Economics in Focus FDA Approval Backed By EXCALIBER-RRMM Trial Data The FDA's decision is anchored in the results of the Phase 3 EXCALIBER-RRMM trial.
