← All approvals · Cancer · 2026
Zenbexus (iberdomide)
The FDA approved Zenbexus (iberdomide) on August 13, 2026 to be used in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
- Brand name
- Zenbexus
- Generic name
- iberdomide
- FDA approval date
- August 13, 2026
- Approved use (FDA wording)
- To be used in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent
- Company
- Bristol Myers Squibb
- Application
- NDA221075
- Dosage form / route
- CAPSULE · ORAL
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Cancer
Indications and usage, from the FDA label
ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and d…