FDA Accepts NDA for Iberdomide in Relapsed or Refractory Multiple Myeloma

The FDA accepted the new drug application (NDA) for iberdomide (Bristol Myers Squibb) in combination with anti-CD38 monoclonal antibodies for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).¹ This regulatory milestone reflects growing interest in next-generation cereblon E3 ligase modulators (CELMoDs) and their potential to improve outcomes in heavily pretreated populations. The submission is supported primarily by data from the phase 3 EXCALIBER-RRMM trial and emphasizes measurable residual disease (MRD) as a clinically meaningful end point.^1,2

For oncology pharmacists, this development highlights an expanding role in optimizing novel oral–immunotherapy combinations, supporting adherence, monitoring safety, and facilitating patient education in complex myeloma regimens.

Unmet Needs in RRMM

Multiple myeloma remains an incurable hematologic malignancy characterized by repeated cycles of remission and relapse. Despite advances in proteasome inhibitors, immunomodulatory drugs (IMiDs), anti-CD38 antibodies, and cellular therapies, many patients eventually develop treatment-resistant disease.³

Patients with RRMM who have already undergone several lines of therapy typically encounter diminishing response rates, shorter progression-free survival, and more adverse effects.³ These challenges clearly demonstrate the necessity for new, innovative drugs that can be safely and effectively combined with current treatment regimens.

Pharmacists are essential to addressing these challenges by evaluating prior treatment history, identifying resistance patterns, and helping guide therapy selection. With iberdomide becoming one of the treatment options, pharmacists will be key players in not only helping to identify suitable patients but also in managing the transition between therapies.

Clinical Evidence Supporting the NDA

The FDA submission is primarily supported by results from the phase 3 EXCALIBER-RRMM trial (NCT04975997), which evaluated iberdomide in combination with anti-CD38–based therapy in patients with RRMM.² The study enrolled adults who had received multiple prior lines of therapy and demonstrated disease progression.

Key study end points included MRD negativity, overall response rate, progression-free survival, and safety.² MRD status is increasingly recognized as a predictor of long-term outcomes and is becoming an important tool in treatment monitoring.³

In announcing the FDA’s acceptance of the application, Bristol Myers Squibb emphasized the clinical significance of these findings. “The FDA’s acceptance of this application is a testament to the potential of iberdomide, in combination with anti-CD38 monoclonal antibodies, as a novel, potent, oral treatment option, with a manageable safety profile, for patients with [MM],” said Cristian Massacesi, MD, executive vice president and chief medical officer. “Furthermore, our filing for iberdomide based on the MRD end point, underscores our commitment to pioneering new ways of advancing life-saving therapies for patients living with cancer.”¹

Pharmacists will increasingly be involved in interpreting MRD data, supporting shared decision-making, and helping clinicians adjust therapy based on depth of response.

Implications for Clinical Practice and Multidisciplinary Care

For oncology pharmacists, this advancement reinforces the importance of multidisciplinary collaboration. Pharmacists will be essential in protocol development, pathway integration, reimbursement navigation, and patient education initiatives. Their involvement will help ensure safe and equitable access to emerging therapies.

Ongoing studies are evaluating iberdomide in combination with additional agents and in less heavily pretreated populations.^2,4 These trials may further define its role across the myeloma treatment continuum and create new opportunities for pharmacist-led clinical services.

REFERENCES

1. U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma. Bristol Myers Squibb. Published February 17, 2026. Accessed February 18, 2026. https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Iberdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

2. NCT04975997. Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (EXCALIBER-RRMM). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT04975997?tab=study

3. Rajkumar SV. Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management. Am J Hematol. 2024;99(9):1802-1824. doi:10.1002/ajh.27422

4. Matyskiela ME, Zhang W, Man HW, et al. A Cereblon Modulator (CC-220) with Improved Degradation of Ikaros and Aiolos. J Med Chem. 2018;61(2):535-542. doi:10.1021/acs.jmedchem.6b01921