FDA Grants Accelerated Approval to Bristol Myers Squibb's Iberdomide Combo for Relapsed Multiple Myeloma, Pressuring Pomalyst and Revlimid

The U.S. Food and Drug Administration on August 18 granted accelerated approval to iberdomide — now branded Zenbexus — in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The approval, confirmed on the FDA's 「Novel Drug Approvals for 2026」 list, is based on a 41 percent minimal-residual-disease-negative complete-response rate in the registrational study and gives Bristol Myers Squibb a successor in the same therapeutic class as its older myeloma drugs Pomalyst and Revlimid.

Why Iberdomide Matters

Iberdomide is a cereblon E3 ligase modulator (CELMoD) — the same mechanistic class as lenalidomide (Revlimid) and pomalidomide (Pomalyst), which together generated tens of billions of dollars in cumulative revenue for Bristol Myers Squibb over the past two decades. Iberdomide was designed to be more potent and selective than its predecessors, with a different binding profile to cereblon that allows deeper degradation of the Ikaros and Aiolos transcription factors that drive multiple myeloma cell survival. The accelerated approval reflects both the strength of the response data and the need for new options in patients who have relapsed after both immunomodulatory and anti-CD38 therapies.

What the Data Show

The registrational study supporting the approval produced a 41 percent MRD-negative complete-response rate at the recommended Phase 2 dose when paired with daratumumab and dexamethasone — a level of depth of response that compares favorably with prior CELMoD-based regimens. MRD-negativity is increasingly used as a regulatory and clinical surrogate endpoint in multiple myeloma because it correlates strongly with progression-free survival. The FDA's accelerated approval pathway requires confirmatory trials, and BMS has those underway.

The Cannibalization Math

The new approval lands in the middle of a brutal stretch for BMS's legacy myeloma franchise. Pomalyst sales fell 71 percent year-on-year in the second quarter, and Revlimid fell 49 percent, as copycat generic competitors — authorized last year under volume-license agreements — began biting into the U.S. market. Zenbexus is BMS's structural response: a more selective CELMoD that is harder for generic competitors to substitute for at the pharmacy counter, and that pairs specifically with the same anti-CD38 antibody (daratumumab) that anchors much of modern myeloma care. The economics are straightforward — Zenbexus launches into a market that BMS no longer fully controls.

What It Means for Patients

For clinicians and patients, the new regimen adds an all-oral triplet-plus-injectable option for second-line and later treatment that brings deeper responses than the prior pomalidomide-based combinations. The FDA approval also notes the need for thromboprophylaxis and routine monitoring for venous thromboembolism, given the class effect. Bristol Myers Squibb said the drug will be available through specialty pharmacy channels within two weeks. The August 18 approval is the latest in a series of FDA decisions expected this quarter, including Regeneron's garetosmab for fibrodysplasia ossificans progressiva, which is under Priority Review with a PDUFA decision also due in August.