How Iberdomide Approval Benefits Rural and Frail Multiple Myeloma Patients

The US Food and Drug Administration (FDA) granted accelerated approval to oral iberdomide (Zenbexus) combined with daratumumab and hyaluronidase-fihj and dexamethasone for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. This regulatory milestone introduces the first approved cereblon E3 ligase modulator (CELMoD) agent, establishing a convenient oral regimen.

For oncology nurses, particularly in community or remote settings, this oral formulation represents a major step forward. Elise Curry, BA, BSN, RN, OCN, a clinical trial nurse navigator with Blood Cancer United, discussed the clinical implications in a recent interview with Oncology Nursing News.

Overcoming Geographic and Clinical Barriers

While cellular therapies and bispecific antibodies expand RRMM options, they require intensive center-based administration and monitoring.

“It's an oral drug, which is wonderful,” Curry noted, emphasizing its value for patients who face structural barriers. “It’s great for those patients who maybe are in the rural setting who aren't in a large academic center who have access to CAR T and all those types of things.” She added that iberdomide is particularly beneficial for “more frail patients” who cannot tolerate highly intensive cellular regimens.

Recommended Dosing and EXCALIBER-RRMM Foundation

Clinical efficacy supporting the approval stems from the Phase 3 EXCALIBER-RRMM trial (NCT04975997). In this randomized study, the iberdomide combination (IberDd) demonstrated a statistically significant minimal residual disease (MRD)-negative complete response (CR) rate of 41% versus 21% with the comparator daratumumab, bortezomib, and dexamethasone (DVd) regimen (p <0.0001).

The recommended dosing schedule for each 28-day cycle includes:

• Iberdomide: 1 mg orally once daily on Days 1 through 21
• Daratumumab and hyaluronidase-fihj: 1,800 mg subcutaneously on Days 1, 8, 15, and 22 of Cycles 1 and 2, and then on less frequent maintenance intervals
• Dexamethasone: 20 mg or 40 mg orally on Days 1, 8, 15, and 22

Essential Nursing Considerations and Safety Protocols

Despite oral convenience, iberdomide requires diligent nursing oversight. Curry highlighted key focus areas:

• Managing Myelosuppression: “One of the key nursing considerations is monitoring for cytopenias,” Curry explained, noting that CELMoDs are “slightly more myelosuppressive” than older immunomodulatory drugs. Clinicians must monitor complete blood counts closely, especially during the first few cycles.
• Infection Prevention: Due to neutropenia risks, patient education is critical. Curry advised reinforcing “hand hygiene, staying away from large crowds, [and] immediately reporting fever.”
• Thrombosis Prophylaxis: Given the boxed warning for serious venous and arterial thromboembolism, thrombosis prevention is essential. “They may be on aspirin, a baby aspirin, or for certain patients anticoagulation [is] appropriate,” Curry stated.
• Teratogenicity and REMS Compliance: Because of the risk of embryo-fetal toxicity, iberdomide is available only through a restricted distribution program. “It is going to be a REMS drug... patients and healthcare providers are going to have to go through the normal process,” Curry warned.

On the positive side, Curry noted that less common toxicities like neuropathy, nausea, and diarrhea occurred "much less often with iberdomide than they did with the lenalidomide trials," making it a highly tolerable alternative for relapsed/refractory myeloma patients.

References

1. Food and Drug Administration. FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma. Food and Drug Administration website. Published August 13, 2026. Accessed August 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone
2. Bristol Myers Squibb. U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma. Press Release. Published February 17, 2026. Accessed August 14, 2026. https://news.bms.com/press-releases/press-release-details/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