Fármacos Anticuerpos Monoclonales para el Tratamiento del Cáncer: una Perspectiva Brasileña
DOI:
https://doi.org/10.32635/2176-9745.RBC.2024v70n1.4462Palabras clave:
Agencia Nacional de Vigilancia Sanitaria, Aprobación de Drogas, Antineoplásico/normas, Anticuerpos MonoclonalesResumen
Introducción: Los anticuerpos monoclonales (mAb) son una importante alternativa terapéutica en el tratamiento del cáncer. Sin embargo, el acceso a esta terapia es desigual en países con diferentes ingresos. Objetivo: Este trabajo buscó comparar los mAb aprobados para su uso contra el cáncer en los EUA con los ya aprobados en Brasil, así como discutir, por el mecanismo de acción, las alternativas terapéuticas disponibles. Método: La lista de mAb aprobados por la FDA fue recopilada de publicación anterior y complementada con datos presentes en el sitio web de esta agencia. El mecanismo de acción, la fecha de aprobación y las indicaciones clínicas se obtuvieron de los prospectos del medicamento en el sitio web de la FDA y los datos sobre la fecha de aprobación por parte de la Anvisa se obtuvieron de consultas en el sitio web de esta agencia. Los fármacos fueron tabulados y organizados según sus características estructurales (murinos, quiméricos, humanizados y humanos) y separados en cuatro grandes grupos, según su mecanismo de acción. Resultados: Hasta 2022, la FDA ha aprobado 48 mAb para su uso contra el cáncer. De ellos, 37 ya fueron aprobados por Anvisa para su uso en Brasil, con el tiempo promedio entre la aprobación en el extranjero y en Brasil es de alrededor de dos años. La mayoría de estos mAb son humanos o humanizados (77%) y varían mucho en cuanto a su mecanismo de acción, siendo el antígeno de linfocitos B CD20 y el checkpoint inmunológico PD-1/PD-L1 las principales dianas farmacológicas de los mAb evaluados. Conclusión: Aunque algunos medicamentos aprobados en el exterior aún no están aprobados en Brasil, la tardanza en ese registro no parece estar relacionada con demora por parte de Anvisa. Además, para la mayoría de los casos de estos medicamentos aún no aprobados en Brasil, existen alternativas terapéuticas disponibles.
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