FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma

The FDA granted accelerated approval to iberdomide (Zenbexus) for adults with multiple myeloma who received at least one prior therapy. Combined with daratumumab, hyaluronidase-fihj, and dexamethasone, it achieved a 41% MRD-negative complete response rate. Due to boxed warnings for embryo-fetal toxicity, Zenbexus requires a restricted REMS program.