The SFDA Grants Breakthrough Designation to "ZENBEXUS" for the Treatment of Adult Patients with Mult

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to ZENBEXUS (Iberdomide), developed by Bristol-Myers Squibb, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy, to be used in combination with daratumumab and dexamethasone

Registration Subject to Full Scientific Evaluation

The SFDA emphasizes that this designation allows ZENBEXUS to be submitted and reviewed under the Breakthrough Track, subject to specific regulatory controls and mechanisms. This designation does not constitute a marketing authorization of the drug in Saudi Arabia. A final decision regarding registration will be announced following a full technical and scientific evaluation of the complete registration dossier.

SFDA Breakthrough Medicine Program Accelerates Access to Quality Treatments

The Program is designed to fast-track critical treatments for patients facing serious diseases. It targets innovative therapeutics that have successfully completed clinical trials, demonstrating safety, efficacy, and distinct therapeutic benefits. By condensing regulatory timelines, the Program significantly expands available treatment options and enables early access to innovative medicines. This strategic pathway directly supports the objectives of the Health Sector Transformation Program, a core pillar of Saudi Vision 2030.

For further information about the Breakthrough Medicine Program, please refer to the guide available on the SFDA website.