New approved uses of antineoplastic agents during the COVID-19 pandemic in Colombia- Part 2: Immune checkpoint inhibitors.

Nuevos registros sanitarios en oncología en Colombia durante la pandemia COVID-19. Parte 2: inhibidores de punto de control inmunológico

During the COVID-19 pandemic, regulatory approval or expanded indications were granted for several immune checkpoint inhibitors in cancer treatment in Colombia. However, for various reasons, the practicing medical community faced difficulties in accessing updated information on these new indications. Objective: to review the new approvals by the National Institute for Food and Drug Surveillance (INVIMA) for immune checkpoint inhibitors with approvals issued between March 2020 and May 2022. Methods: New indications for immune checkpoint inhibitors were searched on the INVIMA website and in media sources. For cost information, Circular 12 for regulated drugs or the reference prices from the Drug Price Information System (SISMED) for unregulated drugs were consulted. A brief literature review was conducted for each indication, with a focus on study design, primary outcomes, grade 3 or higher toxicities, and estimated costs in Colombia. Results: New therapeutic indications were found for ipilimumab (anti-CTLA4), nivolumab (anti-PD1), pembrolizumab (anti-PD1), atezolizumab (anti-PD-L1), durvalumab (anti-PD-L1), and avelumab (anti-PD-L1). Nine new indications were approved between March 2020 and May 2022. Pembrolizumab obtained four new indications, including for colorectal cancer with microsatellite instability or DNA mismatch repair deficiency, triple-negative breast cancer, esophageal cancer, and Hodgkin's lymphoma. The combination of atezolizumab and bevacizumab is indicated for advanced hepatocellular carcinoma. Ipilimumab plus nivolumab (with chemotherapy) is approved for metastatic non-small cell lung cancer. Durvalumab in combination with chemotherapy is indicated for extensive-stage small cell lung cancer. Avelumab is approved for maintenance therapy in advanced urothelial cancer and in combination with axitinib for metastatic renal cell carcinoma. The toxicities observed in the registration studies are consistent with the expected profile for this class of agents. Conclusion: The expansion of the number and scope of regulatory approvals for immune checkpoint inhibitors in Colombia presents an additional opportunity for the benefit of cancer patients.