SFDA becomes first regulatory authority globally to approve registration of 'ZENBEXUS' to treat multiple myeloma in adults

RIYADH — The Saudi Food and Drug Authority (SFDA) has approved the registration of ZENBEXUS (iberdomide) for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and dexamethasone. The SFDA is the first regulatory authority globally to approve the registration of this product.Multiple myeloma is a blood cancer originating in plasma cells within the bone marrow, which can lead to anemia, a low white blood cell count, and weakened immunity, in addition to impaired kidney function and bone damage.ZENBEXUS was previously designated under the Breakthrough Medicine Program, reflecting the SFDA’s efforts to facilitate patient access to specialized treatments within Saudi Arabia. ZENBEXUS belongs to a modern therapeutic class known as cereblon E3 ligase modulators (CELMoD) agents. It works by promoting the degradation of proteins that contribute to the survival and growth of multiple myeloma cells, while enhancing the immune system’s ability to attack these cells.The SFDA stated that the approval was based on results from a pivotal Phase 3 clinical trial involving patients with relapsed or refractory multiple myeloma. The results demonstrated that the use of iberdomide, in combination with daratumumab and dexamethasone, achieved a statistically significant improvement compared to the control treatment.Clinical data indicated that the most prominent adverse reactions of the product included a decrease in the count of certain blood cells, which may increase the risk of infection or anemia, in addition to dizziness, nausea, and rash.The SFDA emphasized the necessity of using the product under specialized medical supervision, with regular monitoring of the patient’s clinical condition and blood test results, in accordance with the approved prescribing leaflet.This approval reflects the SFDA’s continued commitment to innovation and expanding access to advanced treatment options, thereby enhancing healthcare quality in alignment with the goals of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.The SFDA Breakthrough Medicine Program covers medicines that have completed clinical development and demonstrated promising efficacy and safety, as well as a clear therapeutic effect in serious diseases. The program accelerates patient access to specialized therapies, expands available treatment options, and enables earlier access to innovative medicines within a shortened time-frame, in line with the Health Sector Transformation Program and Saudi Vision 2030.