Bristol Myers Squibb wins FDA accelerated approval for ZENBEXUS combo in multiple myeloma
BMY•Bristol Myers Squibb won FDA accelerated approval for ZENBEXUS (iberdomide) with daratumumab and dexamethasone for adults with multiple myeloma who have received at least one prior line of treatment including a proteasome inhibitor and an immunomodulatory agent. Continued approval hinges on confirmatory progression-free survival results in an ongoing cohort.
1. Approval details
The FDA granted accelerated approval for the ZENBEXUS combination based on MRD-negative complete response. The approval covers adults with multiple myeloma who have received at least one prior line of treatment including a proteasome inhibitor and an immunomodulatory agent.
2. Confirmatory results
Continued approval hinges on confirmatory progression-free survival results in an ongoing cohort.
