FDA approves iberdomide + Dd for RRMM

On August 13, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to iberdomide, an oral cereblon E3 ligase modulator (CELMoD), in combination with daratumumab + dexamethasone (IberDd), for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and ≥1 prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).

The approval was based on measurable residual disease (MRD)-negativity data, used as a surrogate endpoint, from an interim analysis of the phase III EXCALIBER-RRMM (NCT04975997) trial, which compared IberDd vs daratumumab + bortezomib + and dexamethasone (DVd) in patients with RRMM and 1–2 prior lines of therapy. The MRD-negative complete response (CR) rate at any time was higher with IberDd at 41% vs 21% in the DVd arm (p < 0.0001). Neutropenia and infections were reported in 90.2% and 78.9% of patients receiving IberDd, and led to treatment discontinuation in 1.0% and 1.5% of patients, respectively. Overall, 7.8% of patients discontinued IberDd because of adverse events (AEs) and 4.9% experienced fatal AEs. Pneumonia was the most common serious AE (26%), and sepsis was the only fatal event reported in more than one patient (1.5%).