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Medicamentos biológicos no cancro da mama não metastizado
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A Biotecnologia e a sua aplicação na área da saúde encontra-se em contínua expansão e a um ritmo que tem permitido estar a par das necessidades e desafios impostos para a melhoria da qualidade de vida nos países desenvolvidos.
Os Medicamentos Biológicos são uma nova categoria de fármacos e permitem o tratamento de patologias específicas para as quais as terapêuticas tradicionais não são suficientemente eficazes. São produzidos a partir de células vivas ao contrário dos medicamentos de síntese química, são compostos por moléculas de grandes dimensões e capazes de desencadear uma resposta imune no organismo.
Os medicamentos biológicos são aprovados segundo o procedimento centralizado, onde a AIM é válida em todos os estados-membros da UE e cujo pedido da mesma é gerido pela EMA. Estão sujeitos a monitorização adicional para recolha de mais informações acerca do seu perfil de segurança.
Alguns exemplos de terapias biológicas em desenvolvimento na área da oncologia são a terapia celular e medicina regenerativa, terapia génica e as medicinas baseadas em moléculas biológicas como a terapia com anticorpos.
O cancro da mama é a patologia oncológica mais diagnosticada e a principal causa de morte nas mulheres. Existem pelo menos seis medicamentos biológicos aprovados para o tratamento de diferentes tipos e fases do cancro da mama: trastuzumab, pertuzumab, lapatinib, trastuzumab emtansina, bevacizumab e everolimus. Alguns destes medicamentos biológicos têm demonstrado resultados bastante promissores no tratamento do cancro da mama HER2 positivo em estadio precoce, nomeadamente o trastuzumab, o pertuzumab e o lapatinib. Existem outras alternativas terapêuticas em estudo, como as vacinas anti-HER2.
Os medicamentos biossimilares, são similares aos seus biológicos de origem e são uma alternativa terapêutica do futuro. Apresentam custos de produção mais baixos e permitem uma maior sustentabilidade dos sistemas de saúde, permitindo o contínuo acesso da inovação aos doentes.
Biotechnology and its application in health is continuously expanding and at a pace that has allowed to be aware of the needs and challenges to improve the quality of life in developed countries. The Biological medicines are a new category of drugs and allow the treatment of specific conditions for which traditional therapies are not effective enough. They are produced from living cells instead of the chemically synthesized drugs, they comprise large molecules and are capable of eliciting an immune response in the body. Biological drugs are approved under the centralized procedure, where the marketing authorization is valid in all EU member states and whose application it is managed by the EMA. They are subject to additional monitoring to collect more information about their safety profile. Some examples of biological therapies in development in the oncology area are cell therapy and regenerative medicine, gene therapy and medicines based on biological molecules such as antibody therapy. Breast cancer is the most diagnosed cancer disease and the leading cause of death in women. There are at least six biological drugs approved for the treatment of different types and stages of breast cancer: trastuzumab, pertuzumab, lapatinib, emtansina trastuzumab, bevacizumab, and everolimus. Some of these biologicals have shown promising results in the treatment of HER2 positive breast cancer in early stage, in particular trastuzumab, pertuzumab, and lapatinib. There are other therapeutic alternatives under study, such as anti-HER2 vaccines. The biosimilar drugs are similar to their biological medicine and are a future alternative therapy. They have lower production costs and allow for greater sustainability of health systems, allowing continuous access of innovation to patients.
Biotechnology and its application in health is continuously expanding and at a pace that has allowed to be aware of the needs and challenges to improve the quality of life in developed countries. The Biological medicines are a new category of drugs and allow the treatment of specific conditions for which traditional therapies are not effective enough. They are produced from living cells instead of the chemically synthesized drugs, they comprise large molecules and are capable of eliciting an immune response in the body. Biological drugs are approved under the centralized procedure, where the marketing authorization is valid in all EU member states and whose application it is managed by the EMA. They are subject to additional monitoring to collect more information about their safety profile. Some examples of biological therapies in development in the oncology area are cell therapy and regenerative medicine, gene therapy and medicines based on biological molecules such as antibody therapy. Breast cancer is the most diagnosed cancer disease and the leading cause of death in women. There are at least six biological drugs approved for the treatment of different types and stages of breast cancer: trastuzumab, pertuzumab, lapatinib, emtansina trastuzumab, bevacizumab, and everolimus. Some of these biologicals have shown promising results in the treatment of HER2 positive breast cancer in early stage, in particular trastuzumab, pertuzumab, and lapatinib. There are other therapeutic alternatives under study, such as anti-HER2 vaccines. The biosimilar drugs are similar to their biological medicine and are a future alternative therapy. They have lower production costs and allow for greater sustainability of health systems, allowing continuous access of innovation to patients.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2016
Palavras-chave
Medicamentos biológicos Imunoterapia Cancro da mama HER2-Positivo Trastuzumab Mestrado Integrado - 2016