WASHINGTON, August 18, 2026 — The U.S. Food and Drug Administration (FDA) has approved iberdomide (Zenbexus®) as part of a combination regimen for adults with multiple myeloma who have already received at least one previous treatment.
The treatment combining iberdomide with daratumumab and hyaluronidase-fihj (Darzalex Faspro) and dexamethasone received an accelerated FDA approval, which is designed to provide earlier access to treatments that fulfill an unmet medical need. Iberdomide works to destroy proteins inside cancer cells in a novel way—different from other treatments for multiple myeloma.
"Each new treatment is an important step forward for people living with multiple myeloma, and new treatments that can be delivered in community hospital settings, where the majority of myeloma care happens, are particularly impactful" said Lore Gruenbaum, Ph.D., Chief Scientific Officer of Blood Cancer United.
In a clinical trial, patients who received the iberdomide combination, were nearly twice as likely to have a complete response to treatment without any evidence of minimal residual disease (MRD) in patients’ bone marrow compared with patients who received a previously approved combination treatment consisting of daratumumab, bortezomib, and dexamethasone.
This marks the first time the FDA used a new approach to speed up how some therapies get accelerated approval. The FDA assessed if a patient's disease responded to treatment by looking for evidence of whether cancer cells could be seen in bone marrow samples.
"This change is cutting many months, if not years in clinical development time so that patients can get access to a new drug sooner," said Dr. Gruenbaum.
The study is ongoing, and researchers will continue to collect data on progression-free survival, which is defined as the time an individual is alive without their disease progressing, to achieve full approval.
“The outlook for people with multiple myeloma continues to improve with longer life expectancy and better quality of life during and after treatment,” added Dr. Gruenbaum.
Funding Foundational Science to Advance Therapies
Blood Cancer United provided funding for the foundational research on protein degraders, such as lenalidomide. Additionally, Blood Cancer United has a long-standing history of funding the development of protein degraders through several venture philanthropy investments and partnerships via its Therapy Acceleration Program. There are also multiple active biomedical research grants that continue to provide funding for innovative research in this field.
“We continue to be encouraged by the sustained progress being made in myeloma research and remain hopeful that advances like this will lead to better outcomes for patients and families," concluded Dr. Gruenbaum.
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