Unpacking Iberdomide’s FDA Approval and The Future of CELMoDs

In August 2026, the FDA granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) and dexamethasone for patients with relapsed/refractory multiple myeloma.¹ The agency’s decision represents the first approval of a CELMoD, a more potent, target-specific successor to immunomodulatory drugs (IMiDs), according to Surbhi Sidana, MD.

In a conversation with CancerNetwork^®, Sidana, an associate professor of medicine at Stanford University, where she leads the myeloma cellular immunotherapy program and chairs the American Society of Hematology (ASH) Committee on Communications, discussed how this regulatory decision may impact the multiple myeloma paradigm. Additionally, she spoke about the potential next steps for the CELMoD class across different treatment lines and settings.

Considering iberdomide’s approval, Sidana described how clinicians have “an option that suits every patient,” although deciding on specific therapeutic strategies represents a different challenge. She detailed how iberdomide will fit alongside modalities like CAR T-cell therapies and bispecific antibodies by serving as a convenient option for patients who are older, frailer, or unable to travel to a center that offers immunotherapy. She also highlighted the potential to combine the CELMoD with other therapies as part of a “sandwich approach.”

Speaking about CELMoDs more broadly, Sidana discussed how the drug class will serve as a complement to CAR T-cell therapy and bispecifics as bridging therapy, maintenance therapy, and even as a post-relapse option. Looking ahead, she foresees CELMoDs gradually moving to the frontline setting, with ongoing trials assessing them in combination regimens for patients with newly diagnosed disease.

“This approval is a landmark approval for several reasons,” Sidana said. “Having [iberdomide] as an option, which is an oral drug and easy to give, is tremendous for our patients. Iberdomide is a CELMoD, which…I think of as IMiDs 2.0. They’re oral, they have a REMS program…and they’re given on a very similar schedule, but they’re more targeted…[with fewer] adverse effects.”

Sidana also highlighted an initiative from ASH named Fight4Hematology, in which members and hematologists from the organization are advocating to legislators and educating the public on the importance of continuing to fund blood disorder and hematology research.²

References

1. FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma. News release. FDA. August 13, 2026. Accessed August 31, 2026. https://tinyurl.com/38258auk
2. #Fight4Hematology Action Hub. American Society of Hematology. Accessed August 31, 2026. https://tinyurl.com/ms94frk9