> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Accelerated Approval for Zenbexus Combo in Multiple Myeloma
- URL: https://www.fdaweb.com/accelerated-approval-for-zenbexus-combo-in-multiple-myeloma/
- Published: 2026-08-13T12:00:00.000Z
- Updated: 2026-09-14T13:45:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161625

FDA has granted Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) 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.

Approval was based on data from EXCALIBER-RRMM (NCT04975997), a two-stage, randomized, multicenter, open-label trial in adults with relapsed or refractory multiple myeloma who had previously received one or two prior lines of therapy, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone?ref=fdaweb.com).

The major efficacy outcome measure in the trial was minimal residual disease (MRD)-negative complete response (CR) at any time. The MRD- negative CR rate at any time was 41% in the iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone arm and 21% in the comparative DVd arm.

FDA says the prescribing information includes a Boxed Warning for embryo-fetal toxicity and serious venous and arterial thromboembolism, as well as warnings and precautions for neutropenia, infections, and secondary primary malignancies. “Because of the risk of embryo-fetal toxicity, iberdomide is available only through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS),” it adds.