India, Aug. 17 -- Bristol Myers Squibb (BMY) announced on Friday that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
ZENBEXUS is the first FDA-approved CELMoD, belonging to a new class called cereblon-modulating protein degraders for the treatment of multiple myeloma.
Approval of ZENBEXUS is based on results from the Phase 3 EXCALIBER-RRMM trial evaluating ZENBEXUS, daratumumab, hyaluronidase-fihj and dexamethasone (ZDd; n=207) compar...