FDA grants accelerated approval to Bristol Myers Squibb’s ZENBEXUS for relapsed multiple myeloma combo use
BMY•FDA grants accelerated approval for relapsed multiple myeloma use
- FDA granted accelerated approval to Bristol Myers Squibb’s ZENBEXUS (iberdomide) with daratumumab and hyaluronidase-fihj, dexamethasone for relapsed multiple myeloma.
- Use covers adults with at least one prior line, including a proteasome inhibitor and an immunomodulatory agent.
- Clearance was based on MRD-negative complete response rate of 41% with ZDd vs 21% with DVd in EXCALIBER-RRMM.
- Full approval depends on confirmatory trials; mezigdomide NDA remains under FDA review with a May 13, 2027 target date.
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