Saudi Arabia Grants World’s First Approval for Iberdomide in Multiple Myeloma | iPharmaCenter

The Saudi Food and Drug Authority has become the first regulatory agency worldwide to approve iberdomide for adults with relapsed or refractory multiple myeloma.

The treatment, marketed as ZENBEXUS, is authorized for use alongside daratumumab and dexamethasone in patients whose disease has returned or no longer responds adequately to earlier treatment.

The SFDA announced the decision on August 11, 2026.

Approval Based on Phase 3 Evidence

The registration was supported by results from a pivotal Phase 3 clinical trial involving patients with relapsed or treatment-resistant multiple myeloma.

According to the SFDA, adding iberdomide to daratumumab and dexamethasone produced a statistically significant improvement compared with the control regimen. The approval marks the first global regulatory authorization for a cereblon E3 ligase modulator in this disease setting.

Iberdomide is being developed as part of a newer class of medicines known as cereblon E3 ligase modulators, or CELMoD therapies.

How the Treatment Works

Multiple myeloma is a blood cancer that begins in plasma cells located in the bone marrow. As the disease progresses, it can interfere with the production of healthy blood cells and contribute to anemia, weakened immunity, kidney problems, and bone damage.

Iberdomide works by promoting the breakdown of proteins that help myeloma cells survive and multiply. The treatment may also strengthen immune activity against malignant plasma cells.

Part of Saudi’s Promising Drugs Program

Before receiving registration approval, the medicine had been included in Saudi Arabia’s Promising Drugs Program.

The initiative is intended for medicines that have completed clinical development stages and demonstrated encouraging evidence of efficacy, safety, and therapeutic value in serious diseases. The program is designed to shorten the time required for eligible treatments to reach patients while expanding available care options.

The SFDA said the decision reflects Saudi Arabia’s wider focus on healthcare innovation and improved access to modern therapies. It also supports the objectives of the Health Sector Transformation Program, one of the programs linked to Saudi Vision 2030.

The approval gives physicians in Saudi Arabia a new treatment option for patients with relapsed or refractory multiple myeloma and establishes the country as the first regulator to authorize iberdomide for this indication.