Saudi Arabia First to Approve ZENBEXUS for Myeloma

Saudi Arabia has become the first country in the world to register a new treatment for a form of blood cancer. The Saudi Food and Drug Authority (SFDA) has approved ZENBEXUS (iberdomide) for adult patients with relapsed or refractory multiple myeloma, marking the first such registration granted by any regulatory authority globally.

ZENBEXUS is to be used in combination with two other medicines — daratumumab and dexamethasone — as part of a treatment regimen for patients whose disease has returned after previous therapy or has not responded to earlier treatment.

Multiple myeloma is a cancer that affects certain white blood cells in the bone marrow. Patients described as having "relapsed or refractory" disease are those whose condition has come back or has proven difficult to control with existing treatments, making new therapeutic options especially significant for this group.

Why it matters

Being the first regulator worldwide to approve this registration places Saudi Arabia at the front of access to a newly available therapy. For patients in the Kingdom and their families, an earlier local registration can mean faster availability of treatment options within the national healthcare system.

The move also reflects the growing role of the SFDA in evaluating and authorizing advanced medicines. Saudi Living will share further details on availability, dispensing channels, and any additional guidance as official information is confirmed.

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