Clinical Report: FDA approves iberdomide for multiple myeloma

Overview

The FDA has granted accelerated approval for iberdomide in combination with daratumumab and dexamethasone for adults with multiple myeloma who have received at least one prior therapy. This approval is based on the phase 3 EXCALIBER-RRMM trial, which demonstrated a significant improvement in minimal residual disease-negative complete response rates, with 41% of patients achieving this outcome compared to 21% in the control group.

Background

Multiple myeloma is a hematologic malignancy characterized by the proliferation of abnormal plasma cells. Treatment options have evolved, but there remains a need for effective therapies for patients who have relapsed after prior treatments. The approval of iberdomide represents a new therapeutic option within the cereblon-modulating protein degrader class, which targets specific pathways involved in the disease.

Data Highlights

Key Findings

• Iberdomide is the first cereblon E3 ligase modulator approved by the FDA.
• 41% of patients receiving iberdomide, daratumumab, and dexamethasone achieved MRD-negative complete response.
• Serious adverse reactions occurred in 58% of patients on the iberdomide regimen, including pneumonia and infections.
• Fatal adverse reactions were reported in 5% of patients receiving iberdomide.
• Common adverse reactions included neutropenia (90%) and infections (79%).

Clinical Implications

Clinicians should be aware of the potential for serious adverse reactions associated with iberdomide, including neutropenia and thromboembolic events, as reported in the trial data.

Conclusion

The approval of iberdomide provides a new option for treating relapsed or refractory multiple myeloma, with data from the EXCALIBER-RRMM trial indicating significant efficacy in achieving MRD-negative complete response.

Related Resources & Content

1. Bristol Myers Squibb, Press Release, 2023 -- FDA approves iberdomide for multiple myeloma
2. The ASCO Post, 2026 -- FDA Approves Isatuximab-irfc for Subcutaneous Injection for Multiple Myeloma Indications
3. The ASCO Post, October 2023 -- FDA Approves Ivosidenib for Myelodysplastic Syndromes
4. The ASCO Post -- Studies Confirm and Extend the Benefits of Ixazomib in Multiple Myeloma
5. Multiple Myeloma, Version 5.2026, NCCN Clinical Practice Guidelines In Oncology
6. MDSpire News — FDA Approves Subcutaneous Isatuximab-irfc
7. EXCALIBER-RRMM: a phase III trial of iberdomide, daratumumab, and dexamethasone in relapsed/refractory multiple myeloma
8. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma
9. Multiple Myeloma, Version 5.2026, NCCN Clinical Practice Guidelines In Oncology - PubMed