FDA grants accelerated approval to Zenbexus combination for previously treated multiple myeloma
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The approval provides adults who have received at least one prior line of therapy with a new iberdomide-based combination, supported by higher minimal residual disease-negative complete response rates than the comparator regimen in EXCALIBER-RRMM.
The US Food and Drug Administration (FDA) has granted accelerated approval to 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.
The approval introduces an iberdomide-based treatment option earlier in the relapsed or refractory multiple myeloma pathway, with continued approval dependent on verification of clinical benefit.
Field | Content |
Alert Type | Drug Approval |
Drug Name | Zenbexus (iberdomide) |
Indication | 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. (U.S. Food and Drug Administration) |
Therapy Area(s) | Haematology; Oncology; Multiple myeloma |
Geography | United States (FDA) |
What Happened | On 13 August 2026, the FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone. The approved population comprises adults with multiple myeloma previously treated with at least one line containing a proteasome inhibitor and an immunomodulatory agent. Iberdomide is administered orally at 1 mg once daily on days 1–21 of each 28-day cycle alongside subcutaneous daratumumab and hyaluronidase-fihj and dexamethasone, with treatment continuing until disease progression or unacceptable toxicity. (U.S. Food and Drug Administration) |
Why It Matters | The approval makes an iberdomide-based regimen available to patients after at least one prior line of therapy, adding another treatment option in relapsed or refractory multiple myeloma. In EXCALIBER-RRMM, the regimen achieved a 41% MRD-negative complete response rate, compared with 21% for daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd); however, accelerated approval is based on this surrogate endpoint and clinical benefit still requires confirmation. (U.S. Food and Drug Administration) |
Supporting Context | EXCALIBER-RRMM was a two-stage, randomised, multicentre, open-label trial involving 939 adults with relapsed or refractory multiple myeloma previously treated with one or two lines of therapy. Patients whose disease was refractory to previous anti-CD38 monoclonal antibody therapy or bortezomib were excluded. The primary efficacy analysis compared 207 patients receiving IberDd with 213 receiving DVd. (U.S. Food and Drug Administration) |
Key Takeaway | FDA accelerated approval adds iberdomide to the treatment options available after at least one previous multiple myeloma regimen, based on a significantly higher MRD-negative complete response rate versus DVd. (U.S. Food and Drug Administration) |
What to Watch | Because Zenbexus received accelerated approval, continued approval for this indication may depend on confirmation of clinical benefit. The prescribing information also carries a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism, and iberdomide is available only through the ZENBEXUS REMS restricted distribution programme because of embryo-fetal toxicity risk. (U.S. Food and Drug Administration) |
Primary Source | |
Relevant Date | 13 August 2026 |
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