SFDA Becomes First Regulatory Authority Globally to Approve the Registration of 'ZENBEXUS' for the T

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 anaemia, 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 Medicines Program, reflecting the SFDA's efforts to facilitate patient access to specialized treatments within Saudi Arabia.

Innovative Mechanism of Action

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. 

Positive Results Demonstrated in Clinical Studies 

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.

Most Common Side Effect
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 anaemia, 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.

A New Step Toward Enhancing the Quality of Healthcare

This approval reflects the SFDA’s continued commitment to innovation and expanding access to advanced treatment options, thereby enhancing the quality of healthcare in alignment with the goals of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.

Breakthrough Medicine Program Accelerates Access to Specialised Therapie

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 specialised therapies, expands available treatment options, and enables earlier access to innovative medicines within a shortened timeframe, in line with the Health Sector Transformation Program and Saudi Vision 2030.

For further details, please refer to the SFDA Breakthrough Medicine Program Guide:https://sfda.gov.sa/en/regulations/89310