FDA Grants Accelerated Approval for Iberdomide in Relapsed/Refractory Multiple Myeloma

The FDA has granted accelerated approval to iberdomide as a combination therapy for adults with relapsed/refractory multiple myeloma. This marks the first approval of a cereblon E3 ligase modulator (CELMoD) for this condition and the first myeloma approval based primarily on measurable residual disease (MRD) data. The decision, based on interim Phase 3 trial results, offers a new treatment option for patients who have received prior therapies, despite a boxed warning for embryo-fetal toxicity and thromboembolism.