Treats multiple myeloma. NDA 221075, held by Bristol Myers Squibb. Iberdomide Hydrochloride.
As of Nov 13, 2026, NDA 221075 (Zenbexus), held by Bristol Myers Squibb, was first approved by FDA on Aug 13, 2026, with 0 approved supplements and 0 published complete response letters.
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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| ZenbexusEQ 0.75MG BASE · capsule;oral | Iberdomide Hydrochloride | RxReference drug |
| ZenbexusEQ 1MG BASE · capsule;oral | Iberdomide Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
