The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s Zenbexus (iberdomide) for adults with relapsed or refractory multiple myeloma, expanding treatment options for patients whose disease has returned or stopped responding to previous therapies.
Zenbexus is approved for use in combination with daratumumab and hyaluronidase-fihj and dexamethasone. The medicine belongs to a newer class known as cereblon E3 ligase modulators, or CELMoDs, which are designed to target the cereblon protein and promote the destruction of myeloma cells.
The FDA granted the medicine accelerated approval based on clinical evidence showing improvement in minimal residual disease outcomes. Continued confirmatory studies will be required to verify clinical benefit for full approval.
The approval also comes with significant safety considerations. Zenbexus carries a boxed warning concerning embryo-fetal toxicity and will be distributed through a restricted program. Bristol Myers Squibb expects the medicine to become available in the United States in the coming weeks.
