Saudi FDA first to approve Zynpexos for multiple myeloma

The Saudi Food and Drug Authority (SFDA) has approved the registration of Zynpexos (iberdomide) for adult patients with relapsed or refractory multiple myeloma, making it the first regulatory body worldwide to authorize this type of treatment.

The medication is used in combination with daratumumab and dexamethasone as part of a treatment plan for patients whose disease has relapsed or become resistant to conventional therapies.

Innovative mechanism and side effects

The SFDA explained that Zynpexos belongs to a new class of medicines known as "cereblon E3 ligase modulators." It works by promoting the breakdown of proteins essential for the survival and growth of cancer cells, and enhances the immune system's response against these cells.

Results from a phase III clinical trial showed that adding iberdomide to the treatment regimen led to a significant statistical improvement compared to other therapies. However, the most notable side effects included reduced levels of certain blood cells, which may increase the risk of infection or anemia, as well as dizziness, nausea, and skin rash.

Facilitating access to advanced therapies

The authority stated that the medication had previously been designated under the Promising Medicines Program, reflecting its efforts to facilitate patient access to innovative treatments within the Kingdom. The SFDA emphasized that the drug should only be used under specialist medical supervision, with regular clinical and blood monitoring as outlined in the approved guidelines.

This approval is part of the SFDA's commitment to supporting innovation and providing advanced treatment options, in line with the objectives of the Health Sector Transformation Program, a key initiative under Saudi Vision 2030.

Promising Medicines Program

The SFDA noted that the Promising Medicines Program aims to accelerate access to effective treatments for serious diseases and expand the range of therapies available to patients. More information is available in the Promising Medicines Program Guide on the authority's website.