The U.S. Food and Drug Administration has accepted a New Drug Application for iberdomide, an oral CELMoD, to be used with Darzalex (daratumumab) and dexamethasone for patients with relapsed or refractory multiple myeloma. The combination, known as IberDd, has received Breakthrough Therapy Designation.
The application is based on interim results from the Phase 3 EXCALIBER-RRMM study. This trial compared IberDd with the standard regimen of daratumumab, bortezomib, and dexamethasone (DVd). IberDd showed a statistically significant improvement in minimal residual disease (MRD) negativity rates compared with the control group. The study is still ongoing to evaluate long-term outcomes such as progression-free survival and overall survival.
Iberdomide belongs to a newer class of drugs called CELMoDs, designed to be more potent than older immunomodulatory drugs like lenalidomide. It works by promoting the degradation of key cancer-related proteins. As an oral treatment, it is more convenient for patients than injectable therapies. Although it can cause blood-related side effects, it is generally considered manageable. In other studies involving newly diagnosed patients, the IberDd combination achieved a high overall response rate of 94.7%, including a 68% complete response rate. The trial enrolled patients who had received one to two prior treatments and excluded those resistant to prior CD38 antibodies or bortezomib.