SFDA Grants Breakthrough Designation to "Wilsirdli" for Early, Advanced, and Metastatic ER+/HER2- Breast Cancer

The Saudi Food and Drug Authority (SFDA) has approved a request by Roche Pharmaceuticals to designate "Wilsirdli" under its Breakthrough Medicine Program. The medication contains the active ingredient giredestrant and is indicated as an adjuvant treatment for adults with early-stage estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer. It is also indicated, in combination with everolimus, for adults with locally advanced or metastatic ER+/HER2- breast cancer.

Registration Subject to Full Scientific Evaluation

The SFDA emphasizes that this designation allows Wilsirdli to be submitted and reviewed under the Breakthrough Track, subject to specific regulatory controls and mechanisms. This designation does not constitute 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 Quality Treatments

The Program is designed to fast-track critical treatments for patients facing serious and life-threatening diseases. It targets innovative therapeutics that have successfully completed clinical trials, demonstrating safety, efficacy, and distinct therapeutic benefits. By condensing regulatory timelines, the Program significantly expands available treatment options and enables early access to innovative medicines.

For further information about the Breakthrough Medicine Program, please refer to the guide available on the SFDA website or contact the Drug Sector Designation Office via email at: Designation.Drug@sfda.gov.sa.