SFDA Grants Breakthrough Designation of a Drug Targeting the Treatment of Certain Types of Cancer Under the Breakthrough Program

The Saudi Food and Drug Authority (SFDA) has announced its approval to designate a drug under the Breakthrough Medicines Program for the treatment of adult patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma whose tumors are CLDN18.2 positive and whose disease progressed during or after at least one prior therapy for locally advanced unresectable or metastatic disease.

The SFDA clarified that the scientific (generic) name of the product is “Sonesitatug vedotin”, submitted by AstraZeneca UK.

Registration is Subjected to Full Scientific Evaluation 

The SFDA emphasizes that this designation allows Adenocarcinoma 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 Targeted 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. Through this program, the SFDA aims to expedite patient access to advanced treatments and broaden available therapeutic options when standard medications prove insufficient, ensuring timely access to innovative drugs within a shortened timeframe.

To qualify for Breakthrough designation, the drug must target serious, debilitating, or life-threatening conditions where the anticipated therapeutic benefits outweigh potential risks. Furthermore, it must offer a significant therapeutic advantage over existing treatments and must not be registered with any other regulatory authority at the time of application.

For further details, please refer to the Breakthrough Medicine Program Guide available on the official SFDA website. Direct inquiries may be submitted to the SFDA Drug Designation Unit via email at (Designation.Drug@sfda.gov.sa).