Abstract
Abstract
Immunotherapy has been shown to successfully turn aggressive malignancies in many patients into curable diseases. Thus, immunotherapy has received so much attention internationally, and Saudi Arabia was not an exception. Here, we evaluated the status of regulatory-approved immunotherapies in Saudi Arabia using the Saudi Food and Drug Administration (sFDA) database and the ClinicalTrials.gov website. We found that not all available immunotherapies in the clinic worldwide are approved by the sFDA, and the number of Saudi immunotherapy clinical trials are very limited. In fact, out of the eight regulatory-approved immune checkpoint inhibitors, 5 have received the sFDA approval. These immune check point inhibitors are Yervoy (ipilimumab), Nivolumab (Opdivo), Pembrolizumab (Keytruda), Atezolizumab (Tecentriq) and Avelumab (Bavencio). Also, out of the 5 regulatory approved chimeric antigen receptor (CAR) T cell therapy products, only KYMRIAHTM (tisagenlecleucel) has received the sFDA approval. According to the ClinicalTrials.gov registry (accessed 27 July 2021), only 6 investigational clinical trials have been conducted in Saudi Arabia to evaluate immune check point inhibitors, and only 3 of these studies are currently ongoing. More surprisingly, no Saudi CAR clinical trials have yet been conducted. Taken together, there is an urgent need for a greater accessibility for immunotherapy in the country.
Citation Format: Reham Ajina. Current status of regulatory-approved immunotherapies in Saudi Arabia [abstract]. In: Abstracts: AACR Virtual Special Conference: Tumor Immunology and Immunotherapy; 2021 Oct 5-6. Philadelphia (PA): AACR; Cancer Immunol Res 2022;10(1 Suppl):Abstract nr P067.