FDA Grants Accelerated Approval for Iberdomide in Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This decision is supported by data from the Phase 3 EXCALIBER-RRMM trial, which showed a statistically significant improvement in minimal residual disease (MRD) negativity rates.