ZENBEXUS (iberdomide) + daratumumab and hyaluronidase-fihj + dexamethasone
Previously treated multiple myeloma · Adults who received at least one prior line including a proteasome inhibitor and an immunomodulatory agent
BMY · BMYBristol-Myers Squibb Company
Regulatory designations
Full timeline
5 milestonesOriginal PDUFA date superseded by early approval
FDA had assigned August 17 as the target action date for the iberdomide combination NDA. The agency granted accelerated approval on August 13, four days before the goal date.
Bristol Myers Squibb — NDA acceptance and August 17 action date↗FDA granted accelerated approval to ZENBEXUS combination
FDA granted accelerated approval to ZENBEXUS (iberdomide) with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma after at least one prior line containing a proteasome inhibitor and an immunomodulatory agent. In EXCALIBER-RRMM, the MRD-negative complete-response rate was 41% with the iberdomide regimen versus 21% with the comparator.
FDA — Accelerated approval of iberdomide combination↗FDA accepted the iberdomide combination NDA
FDA accepted the application, granted Priority Review and Breakthrough Therapy designation for this indication, and assigned the August 17 action date.
Bristol Myers Squibb — FDA acceptance of the iberdomide NDA↗EXCALIBER-RRMM interim analysis was positive
The Phase 3 study showed a statistically significant improvement in minimal residual disease negativity versus the control regimen at the planned interim analysis. The trial continued to evaluate progression-free survival, overall survival and safety.
Bristol Myers Squibb — EXCALIBER-RRMM interim results↗Related News
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