Fármacos Anticorpos Monoclonais para o Tratamento do Câncer: uma Perspectiva Brasileira
DOI:
https://doi.org/10.32635/2176-9745.RBC.2024v70n1.4462Palavras-chave:
Agência Nacional de Vigilância Sanitária, Aprovação de Drogas, Antineoplásicos/normas, Anticorpos MonoclonaisResumo
Introdução: Os anticorpos monoclonais (mAb) são alternativa terapêutica importante no tratamento do câncer. Porém, o acesso a essa terapia é desigual entre países com diferentes rendas. Objetivo: Comparar os fármacos mAb aprovados para uso contra câncer nos EUA com os aprovados no Brasil e discutir, por meio do mecanismo de ação, alternativas terapêuticas disponíveis. Método: A lista de fármacos mAb aprovados pelo FDA foi coletada de publicação prévia e complementada com dados presentes no site dessa agência, assim como mecanismo de ação, data de aprovação e indicações clínicas foram obtidos das bulas dos medicamentos nesse mesmo site. Da mesma forma, os dados de data de aprovação pela Anvisa foram obtidos em consultas ao site dessa agência. Os fármacos foram tabelados e organizados conforme características estruturais e separados em quatro grandes grupos, conforme seu mecanismo de ação. Resultados: Até 2022, 48 mAb foram aprovados para uso contra o câncer pelo FDA. Destes, 37 foram aprovados pela Anvisa para uso no Brasil, com tempo médio entre aprovação no exterior e no Brasil próximo a dois anos. A maioria dos mAb são humanos ou humanizados (77%) e variam bastante com relação ao mecanismo de ação, sendo o antígeno de linfócitos B CD20 e o checkpoint imunológico PD-1/PD-L1 os principais alvos dos mAb avaliados. Conclusão: Apesar de alguns fármacos aprovados no exterior ainda não estarem aprovados no Brasil, o atraso para registro não parece estar relacionado à demora da Anvisa. Além disso, para a maioria dos casos de fármacos ainda não aprovados no Brasil, existem alternativas terapêuticas disponíveis.
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