FDA approves iberdomide for multiple myeloma treatment

The US Food and Drug Administration (FDA) has granted accelerated approval to iberdomide, an oral CELMoD class agent, for the treatment of adult patients with relapsed or refractory multiple myeloma. The therapy is administered in combination with daratumumab and dexamethasone for patients who have previously received at least one line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

This approval is supported by the results of the international, randomized, multicenter Phase III EXCALIBER-RRMM clinical study. In the primary efficacy analysis, the combination of iberdomide, daratumumab, and dexamethasone achieved a complete response with negative minimal residual disease (MRD-negative) in 41% of patients, compared to 21% for the standard combination of daratumumab, bortezomib, and dexamethasone.

Greek researchers played a significant role in the study. The Therapeutic Clinic of the Medical School at the National and Kapodistrian University of Athens served as a study center, led by principal investigator Professor Maria Gavriatopoulou. Additionally, Professor Thanos Dimopoulos, Director of the clinic, serves on the international Steering Committee for the study.