Time until Oncologic Treatment Approval in Brazil Compared to Europe and the United States

Abstract Oncology therapy development has accelerated worldwide, with approvals based on safety and efficacy. This study compares approval timelines in Brazil, the United States, and Europe from 2010 to 2021, highlighting regulatory differences and their impact on patient access. In Brazil, after Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA, in Portuguese) approval, oral drugs require National Supplementary Health Agency (ANS, Agência Nacional de Saúde Suplementar, in Portuguese) review for private coverage, and all drugs need National Committee for Health Technology Incorporation (Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde, CONITEC, in Portuguese) evaluation for public incorporation, further delaying access. To compare approval times for novel oncology therapies in Brazil, the US, and Europe over the past decade, and to evaluate secondary approval processes in Brazil (ANS and CONITEC). Regulatory databases were reviewed to identify oncology therapies approved between 2010 and 2021. Kaplan-Meier curves estimated median approval times (95%CI), and Cox regression assessed differences. The National Supplementary Health Agency and CONITEC timelines were analyzed to estimate access in Brazil. In total, 61 drugs were included (2010–2021). The Food and Drug Administration (FDA) had the shortest median approval time: 184 days (95%CI: 168–236), followed by ANVISA: 331 days (95%CI: 327–382), and the EMA: 426 days (95%CI: 391–453). In Brazil, 35 therapies were oral; by 2021, 27 had ANS coverage while 8 (23%) had not been incorporated. Only three therapies were approved by CONITEC. The median ANS approval time was 940 days (95%CI: 786–1444), and the median CONITEC time was 2,816 days (95%CI: 1,652–not estimable). Although ANVISA was faster than the EMA, additional Brazilian reviews by ANS and CONITEC substantially delayed patient access. Streamlining these processes and adopting reliance mechanisms are critical to ensuring more timely and equitable availability of innovative cancer therapies.