The U.S. Food and Drug Administration has approved iberdomide in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma, making it the first approved cereblon E3 ligase modulator (CELMoD) for this disease.
Researchers at Dana-Farber Cancer Institute played an important role in helping advance iberdomide to approval. Dana-Farber investigators contributed to early phase 1/2 research as part of a multi-center effort, including correlative laboratory-based work, and the institute also participated in and advised on the phase 3 clinical trial that supported the regulatory submission. Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber, is a senior author on iberdomide research and served on the steering committee involved in the drug's pivotal phase 3 study and its overall development.
"Dana-Farber has been deeply involved in the development of CELMoDs including iberdomide, from basic translational and clinical studies through later-stage research, all of which have helped bring this therapy earlier to US approval," said Richardson. "This approval reflects the strength of our collaborative clinical and laboratory science dedicated to real world application, and our commitment to translating promising discoveries into new treatment options for our patients with multiple myeloma."
Iberdomide is an oral investigational agent designed to modulate cereblon, a key protein target central to myeloma pathobiology. The approval provides an important new treatment option for patients whose disease has returned or become resistant to prior therapies and provides a platform for its development in earlier settings.
"For patients with relapsed or refractory multiple myeloma, each new effective therapy matters, especially one from a new class that may offer another path forward," said Omar Nadeem, MD, clinical director of the Myeloma Immune Cell Therapy Program at Dana-Farber. "In clinical trials, we saw that overall patients responded well to iberdomide with favorable tolerability, and this approval expands the options available as we work to achieve deeper and more durable responses for our patients."
Dana-Farber continues to investigate CELMoD-based strategies in multiple myeloma, including iberdomide and its more potent partner mezigdomide, through ongoing clinical trials in relapsed/refractory disease and planned studies in newly diagnosed patients. Ongoing work includes iberdomide-based combinations aimed at improving outcomes after CAR T-cell therapy and exploring next-generation regimens earlier in treatment.
