Iberdomide + daratumumab + dexamethasone
Relapsed or refractory multiple myeloma · Patients with relapsed or refractory multiple myeloma
BMY · BMYBristol-Myers Squibb Company
Regulatory designations
Full timeline
4 milestonesFDA decision expected
PDUFA target action date for the iberdomide, daratumumab and dexamethasone combination NDA.
Bristol Myers Squibb — NDA acceptance and August 17 action date↗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↗Phase 3 EXCALIBER-RRMM study started
The randomized pivotal study began evaluating iberdomide plus daratumumab and dexamethasone against the standard comparator regimen in relapsed or refractory multiple myeloma.
ClinicalTrials.gov — EXCALIBER-RRMM study record (NCT04975997)↗Related News
U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse
Aug 13, 2026U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse
Aug 10, 2026Bristol Myers Squibb Advances U.S. Manufacturing Investment with New $2.3 Billion Campus in Houston, Texas
Jul 30, 2026Bristol Myers Squibb Reports Second Quarter Financial Results for 2026
Jul 20, 2026Bristol Myers Squibb to Build the Most Powerful AI Factory in Life Sciences with NVIDIA