Immune checkpoint inhibitors for the treatment of non-small cell lung cancer: The regulatory journey in Brazil

被引：0

作者：

da Veiga, Cassia Rita Pereira ^{[1
]}

da Veiga, Claudimar Pereira ^{[2
]}

Machado, Erika ^{[3
]}

Drummond-Lage, Ana Paula ^{[4
]}

机构：

[1] Univ Fed Minas Gerais, Sch Nursing, Dept Hlth Management, 190 Alfredo Balena, BR-30130100 Belo Horizonte, MG, Brazil

[2] Fundacao Dom Cabral FDC, 760 Princesa Diana, BR-34018006 Nova Lima, MG, Brazil

[3] Univ Sao Paulo, Sch Pharm, Av Prof Lineu Prestes 580, BR-05508000 Sao Paulo, SP, Brazil

[4] Fac Med Sci Minas Gerais, Postgrad Program, Alameda Ezequiel Dias 275, BR-30130110 Belo Horizonte, MG, Brazil

来源：

CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY | 2023年 / 192卷

关键词：

Non -small cell lung cancer; Immune checkpoint inhibitors; Anvisa; FDA; Regulatory approval; OPEN-LABEL; NIVOLUMAB; DOCETAXEL; PHASE-3; PEMBROLIZUMAB; CHEMOTHERAPY; MULTICENTER;

D O I：

10.1016/j.critrevonc.2023.104138

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页数：12

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