CELMoD Wins “Landmark Approval” in Relapsed/Refractory Multiple Myeloma

The FDA’s accelerated approval of iberdomide (Zenbexus) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro) and dexamethasone for relapsed/refractory multiple myeloma marks the first approval in the disease based on a minimal residual disease (MRD) end point, as well as the first for any CELMoD.¹

Surbhi Sidana, MD, 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, spoke with CancerNetwork^® about what this approval means for patients with relapsed/refractory multiple myeloma. She described iberdomide as an evolution of the immunomodulatory drug class based on its more targeted nature.

Transcript:

CancerNetwork: What does this accelerated approval of iberdomide-based treatment mean for patients with relapsed/refractory multiple myeloma?

Sidana: This approval is a landmark approval for several reasons, the first of which is it’s our first approval in multiple myeloma based on an MRD end point. MRD, or measurable residual disease, or minimal residual disease, is looking at myeloma plasma cells at very low levels: 1 in 100,000 or 1 in a million. [In 2024], we heard from the FDA, based on the recommendations of the Oncologic Drugs Advisory Committee (ODAC), that they were open to using MRD as an end point for drug approval.² This was years in the making. A lot of effort from academic myeloma practice, our industry sponsors, organizations that work in myeloma like the International Myeloma Foundation, and several ASH members. We got together, got the data that MRD is a surrogate for survival outcomes, and the FDA accepted it. This is the first approval based on that. Drug agnostic, it’s historic for our field in general, because progression-free survival [PFS] now takes several years. We can’t wait several years to get these drugs into our patients’ hands. We want to get them to our patients early, and so this is a trailblazer in that sense.

Coming back to iberdomide, having that as an option, which is an oral drug and easy to give, is tremendous for our patients. Iberdomide is a CELMoD, which for those who are familiar with myeloma practice, I think of as immunomodulatory drugs, but better: 2.0. They’re oral, they have a REMS program, which we can talk about that’s very similar, and they’re given on a very similar schedule, but they’re more targeted, which means more target specific [with fewer adverse] effects.

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 24, 2026. https://tinyurl.com/38258auk
2. April 12, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC). Streamed live April 12, 2024. Accessed August 24, 2026. https://tinyurl.com/2tbe3f4k