Shots:
- The US FDA has accepted the NDA of iberdomide + daratumumab & dexamethasone (IberDd) for the treatment of pts with r/r multiple myeloma, with submission to be reviewed under Project Orbis (PDUFA: Aug 17, 2026)
- NDA was supported by the planned analysis of MRD negativity rates in the P-III (EXCALIBER-RRMM) trial assessing IberDd vs daratumumab + bortezomib + dexamethasone (DVd) in pts with r/r multiple myeloma
- The trial has 2 stages: Stage 1 identified iberdomide (1mg) as the optimal dose based on safety, PK, & efficacy data, while Stage 2 randomized ~664 pts to IberDd or DVd
Ref: BMS | Image: BMS | Press Release
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