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Immune checkpoint inhibitors for the treatment of non-small cell lung cancer: The regulatory journey in Brazil.
da Veiga, Cássia Rita Pereira; da Veiga, Claudimar Pereira; Machado, Erika; Drummond-Lage, Ana Paula.
Afiliación
  • da Veiga CRP; Department of Health Management, School of Nursing, Federal University of Minas Gerais, 190 Alfredo Balena, Belo Horizonte 30130-100, MG, Brazil.
  • da Veiga CP; Fundação Dom Cabral-FDC, 760 Princesa Diana, Alphaville, Lagoa dos Ingleses, Nova Lima 34018-006, MG, Brazil.
  • Machado E; School of Pharmacy, São Paulo University, Av. Prof. Lineu Prestes, 580, São Paulo 05508-000, SP, Brazil.
  • Drummond-Lage AP; Post-Graduation Program, Faculty of Medical Sciences of Minas Gerais, Alameda Ezequiel Dias, 275, Belo Horizonte 30130-110, MG, Brazil. Electronic address: apdrummond@gmail.com.
Crit Rev Oncol Hematol ; 192: 104138, 2023 Dec.
Article en En | MEDLINE | ID: mdl-37739145
BACKGROUND: Recent therapeutic advances such as immune checkpoint inhibitors (ICIs) have impact on the care of non-small cell lung cancer (NSCLC) patients, however, they bring new setbacks for regulatory agencies. OBJECTIVE: To evaluate the regulatory journey of ICIs registered for NSCLC treatment in Brazil and to establish comparisons of Brazilian regulatory agency with the US regulatory agency. METHODS AND DATA SOURCE: Information for each ICI prescribing as well as the date of regulatory approval of the therapeutic indications of interest were collected from the Anvisa and the FDA websites. The search took place on October 2022. KEY FINDINGS: There are only 20 % disagreements on regulatory approvals between Anvisa and FDA. The prioritization review at Anvisa in 2008 has made the regulatory assessment faster. CONCLUSIONS: The results of this study identified a potential improvement in Anvisa's time performance to connect the target established by the legal framework of the sector.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Prognostic_studies Límite: Humans País/Región como asunto: America do sul / Brasil Idioma: En Revista: Crit Rev Oncol Hematol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Prognostic_studies Límite: Humans País/Región como asunto: America do sul / Brasil Idioma: En Revista: Crit Rev Oncol Hematol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Países Bajos