Iberdomide + daratumumab + dexamethasone
Relapsed or refractory multiple myeloma · Patients with relapsed or refractory multiple myeloma
BMY · BMYBristol-Myers Squibb Company
規制上の指定
全タイムライン
4 件のマイルストーンFDA 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)↗関連ニュース
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
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