New approved uses of antineoplastic agents during the COVID-19 pandemic in Colombia- Part 1: Oral antineoplastic agents, cytotoxic agents, and monoclonal antibodies excluding immune checkpoint inhibitors. Nuevos registros sanitarios en oncología en Colombia durante la pandemia COVID-19. Parte 1: antineoplásicos orales, agentes citotóxicos y anticuerpos monoclonales excluyendo inhibidores de punto de control inmunológico

Abstract

During the COVID-19 pandemic, regulatory approval or indication expansion was obtained for several antineoplastic agents in Colombia. Simultaneously, due to various reasons, the practicing medical community faced difficulties in accessing updated information on these new indications. Therefore, this review aims to examine the new approvals by the National Institute for Surveillance of Drugs and Food (INVIMA) for original antineoplastic agents with approval issued between March 2020 and May 2022. Methods: A search was conducted for new indications of original oral medications (including targeted therapy and endocrine therapy), cytotoxic agents, and monoclonal antibody antineoplastics (excluding immune checkpoint inhibitors addressed in part 2), by requesting INVIMA's records of new approvals from the 10 pharmaceutical companies represented in Colombia and through the INVIMA electronic platform while it was available. For cost information, Circular 12 for regulated medications or the reference prices from the Drug Price Information System (SISMED) for non-regulated medications were consulted. A brief literature review was performed for each indication, emphasizing study design, primary outcomes, grade 3 or higher toxicities, along with estimated costs in Colombia. Results: Regulatory approval or indication expansion in Colombia was documented for 13 medications based on phase 3 studies that demonstrated benefits in progression-free survival (or disease-free survival for non-metastatic disease) or overall survival. These include androgen receptor antagonists such as apalutamide and darolutamide; kinase inhibitors and targeted therapy such as abemaciclib, cabozantinib, ixazomib, lenvatinib, osimertinib, regorafenib, larotrectinib, olaparib, pertuzumab, venetoclax, as well as the cytotoxic agent eribulin. The approvals expand therapeutic options in Colombia for prostate cancer, breast cancer, thyroid cancer, hepatocellular carcinoma, and renal cancer. Most of the new indications were in the context of advanced cancer, but there were also studies in early stages. Conclusion: The expansion of regulatory approvals for antineoplastic agents in Colombia represents an additional opportunity for the benefit of cancer patients.