The U.S. Food and Drug Administration has accepted a New Drug Application (NDA) for iberdomide, a novel oral agent, for use in combination with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM), Bristol Myers Squibb announced today.
This marks a significant milestone for iberdomide, which is designed as the first in a new class of medicines called cereblon E3 ligase modulators (CELMoDs). The FDA has granted Breakthrough Therapy Designation and Priority Review for this indication, signaling the potential to address a critical unmet need in RRMM treatment. A target action date for the FDA’s decision has been set for August 17, 2026.
The NDA submission is based on clinical trial data evaluating the efficacy and safety of iberdomide in combination with standard therapies. The combination, known as IberDd, is being investigated for patients who have already received prior treatment for multiple myeloma. Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell, and is often characterized by cycles of remission and relapse.
According to Bristol Myers Squibb, the FDA’s acceptance of the NDA will trigger a Prescription Drug User Fee Act (PDUFA) review process. This process involves a thorough evaluation of the submitted data by the FDA to determine whether the benefits of iberdomide outweigh its risks.
Iberdomide functions by selectively modulating the cereblon E3 ligase complex, leading to the degradation of specific proteins involved in multiple myeloma cell growth and survival. This targeted approach aims to maximize therapeutic efficacy while minimizing off-target effects.
