SFDA First Worldwide to Approve Zenbexus for Myeloma

The Saudi Food and Drug Authority (SFDA) has become the first regulatory authority in the world to approve the registration of Zenbexus (iberdomide) for the treatment of adult patients with relapsed or refractory multiple myeloma. The approval, announced via official Saudi channels on 11 August 2026, authorizes the medicine for use as an add-on therapy in combination with daratumumab and dexamethasone, marking a significant milestone in the Kingdom’s growing role as a global leader in pharmaceutical innovation and patient access.

Context and Background

Multiple myeloma is a malignant blood cancer that arises in the plasma cells of the bone marrow. The disease can lead to anemia, reduced white blood cell counts, weakened immunity, kidney dysfunction, and damage to bone tissue. For patients whose disease has relapsed or become refractory to prior treatments, therapeutic options have historically been limited, making new treatment pathways a critical area of medical need worldwide.

The SFDA reported that Zenbexus had previously been granted status under its Promising Medicines Designation Program, an initiative that reflects the Authority’s efforts to ease patient access in the Kingdom to specialized treatments. This program targets medicines that have completed clinical trial stages and demonstrated encouraging efficacy, safety, and a pronounced therapeutic effect in treating serious diseases, helping to accelerate access to innovative therapies within compressed timelines.

How Zenbexus Works

According to the SFDA, the medicine belongs to a new therapeutic group known as cereblon E3 ligase modulators. Its mechanism of action works by stimulating the breakdown of proteins that support the survival and growth of multiple myeloma cells, while also strengthening the immune system’s ability to attack these cells. This dual approach represents a notable advance in the targeted treatment of blood cancers.

The registration decision was based on the results of a pivotal Phase III clinical trial involving patients with relapsed or refractory multiple myeloma. The findings showed that the use of iberdomide as add-on therapy in combination with daratumumab and dexamethasone delivered a statistically significant improvement in outcomes compared with the control group. Clinical data indicate that among the most common side effects observed were reductions in certain blood cell counts, which may increase the risk of infection or anemia, along with dizziness, nausea, and skin rash.

Safety Guidance and Medical Oversight

The SFDA emphasized that the medicine must be used exclusively under the supervision of medical specialists, with regular monitoring of clinical condition and blood test results in accordance with the approved instructions. This careful approach underscores the Kingdom’s commitment to patient safety alongside rapid access to advanced therapies.

The Authority confirmed that its Promising Medicines Designation Program is designed to expand available treatment options and ensure early access to innovative medicines. Those wishing to review further details are invited to consult the Promising Medicines Designation Program guide, available on the official SFDA website at https://sfda.gov.sa/en/regulations/89310.

Implications and International Impact

By becoming the first regulatory authority globally to register Zenbexus, the SFDA demonstrates the increasing international weight of Saudi Arabia’s regulatory framework. This milestone positions the Kingdom as a trusted early mover in evaluating cutting-edge therapies, with potential ripple effects for how quickly patients in the region and beyond can access new oncology treatments. It also reinforces confidence among global pharmaceutical companies considering the Saudi market for the launch of innovative medicines.

For patients living with relapsed or refractory multiple myeloma, the approval opens a new combination therapy option that has demonstrated statistically significant benefit in late-stage trials. The decision signals that Saudi Arabia’s regulatory processes are both rigorous and efficient, balancing scientific scrutiny with the urgency of unmet medical need.

Vision 2030 Alignment

This decision embodies the Authority’s commitment to supporting innovation in the health sector and providing patients with modern therapeutic options, thereby contributing to higher quality healthcare in line with the goals of the Health Sector Transformation Program, one of the programs of Saudi Vision 2030. As the Kingdom continues to strengthen its health ecosystem, regulatory achievements such as this one reinforce its ambition to be a global hub for medical innovation, scientific excellence, and improved quality of life for all.

20 Questions

Q1. What did the SFDA approve regarding Zenbexus?

A1. The SFDA approved the registration of Zenbexus (iberdomide) for treating adult patients with relapsed or refractory multiple myeloma, making it the first regulatory authority worldwide to register this medicine.

Q2. When was the approval announced?

A2. According to official Saudi channels, the approval was announced on 11 August 2026, corresponding to 28 Safar 1448 in the Hijri calendar, from Riyadh.

Q3. What is multiple myeloma?

A3. Multiple myeloma is a malignant blood disease arising in the plasma cells of the bone marrow, which can cause anemia, lower white blood cell counts, weakened immunity, kidney problems, and bone damage.

Q4. How is Zenbexus used in treatment?

A4. Zenbexus is approved as add-on therapy in combination with daratumumab and dexamethasone for adult patients whose multiple myeloma has relapsed or become refractory to previous treatments.

Q5. What therapeutic group does the medicine belong to?

A5. The medicine belongs to a new therapeutic group known as cereblon E3 ligase modulators, which target specific protein pathways involved in cancer cell survival.

Q6. How does iberdomide work in the body?

A6. It stimulates the breakdown of proteins that help multiple myeloma cells survive and grow, while also strengthening the immune system’s ability to attack those cancer cells.

Q7. What evidence supported the registration decision?

A7. The decision was based on a pivotal Phase III clinical trial involving patients with relapsed or refractory multiple myeloma, which showed statistically significant improvements over the control group.

Q8. What were the common side effects reported?

A8. Common side effects included reductions in certain blood cell counts, which may raise the risk of infection or anemia, as well as dizziness, nausea, and skin rash in some patients.

Q9. Are there conditions for using Zenbexus?

A9. Yes. The SFDA stressed the medicine must be used only under specialist medical supervision, with regular monitoring of clinical condition and blood test results per the approved instructions.

Q10. What is the Promising Medicines Designation Program?

A10. It is an SFDA initiative targeting medicines that have completed clinical trials and demonstrated encouraging efficacy, safety, and strong therapeutic effects for serious diseases, easing patient access to specialized treatments.

Q11. Did Zenbexus previously receive any special status?

A11. Yes. The SFDA reported the medicine was previously granted status under its Promising Medicines Designation Program, reflecting efforts to ease access for patients in the Kingdom.

Q12. Why is this approval significant globally?

A12. It marks the first time any regulatory authority worldwide has registered this medicine, highlighting Saudi Arabia’s growing role as an early evaluator of innovative cancer therapies.

Q13. What does the approval mean for patients in Saudi Arabia?

A13. It provides a new combination therapy option that showed significant benefit in trials, expanding treatment choices for patients with relapsed or refractory multiple myeloma in the Kingdom.

Q14. Where can people find more program details?

A14. The Promising Medicines Designation Program guide is available on the official SFDA website at https://sfda.gov.sa/en/regulations/89310 for those seeking further information.

Q15. How does this reflect on Saudi Arabia’s regulatory capabilities?

A15. It demonstrates that Saudi Arabia’s regulatory framework is both rigorous and efficient, capable of evaluating cutting-edge oncology therapies faster than other global authorities.

Q16. What is the Health Sector Transformation Program?

A16. It is one of the programs of Saudi Vision 2030 aimed at improving healthcare quality, access, and innovation across the Kingdom, supporting modern therapeutic options for patients.

Q17. Could this approval attract pharmaceutical investment?

A17. Yes. Early registration of innovative medicines can strengthen confidence among global pharmaceutical companies considering the Saudi market for launching new therapies, supporting economic and health goals.

Q18. Who should administer or prescribe Zenbexus?

A18. Only qualified medical specialists should prescribe and administer the medicine, ensuring compliance with approved instructions and continuous monitoring of patient safety and clinical outcomes.

Q19. What monitoring is required during treatment?

A19. Regular monitoring of the patient’s clinical condition and blood test results is required, in accordance with the approved instructions, to manage potential side effects such as reduced blood cell counts.

Q20. How does this align with Saudi Vision 2030?

A20. The approval supports innovation in the health sector and expands patient access to modern therapies, advancing the Health Sector Transformation Program and Vision 2030’s quality-of-life objectives.

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