Journal of cancer policy · 2026
Regulatory approval of new oncology drugs, 2020-2024: A comparative analysis of FDA, EMA, and ANVISA.
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da Silva Alciellen Mendes, Meira Eduardo Frizzera, Dos Santos Jéssica Barreto Ribeiro, da Silva Michael Ruberson Ribeiro
Аннотация
CONTEXT: Cancer remains a leading cause of global mortality, increasing demand for effective and accessible therapies. Regulatory agencies are central to evaluating and approving new oncological technologies.
OBJECTIVES: To compare oncology drug approvals by the FDA, EMA, and ANVISA from 2020 to 2024, analyzing regulatory timelines, innovation profiles, therapeutic trends, and the interval between approval and incorporation into Brazil's Unified Health System (SUS).
METHODS: A retrospective study was conducted using publicly available data from the FDA, EMA, ANVISA, and the National Commission for Health Technology Incorporation (CONITEC). All first-time oncology drug approvals during the period were included. Approval dates, developer origin, exclusivity status, and time to potential SUS incorporation were assessed.
RESULTS: The FDA granted 73 approvals, followed by the EMA (56) and ANVISA (18). Regulatory convergence was high between the FDA and EMA, whereas ANVISA showed median approval delays of 353 days compared with the FDA and 336 days compared with the EMA. Relatively balanced distribution between biological and synthetic medicines was observed, with approvals concentrated among US-headquartered companies and primarily indicated for lung cancer, multiple myeloma, and breast cancer. FDA and EMA decisions relied on a more heterogeneous mix of trial phases and designs, whereas ANVISA more frequently required phase 3 randomized studies. Incorporation into SUS remained limited.
CONCLUSION: Greater integration between regulatory evaluation and health technology assessment is needed to reduce asymmetries and improve timely access to oncological innovations within SUS.
POLICY SUMMARY: Differences in oncology drug approvals across regulatory agencies contribute to delays in access to innovative cancer therapies in Brazil. Strengthening regulatory alignment and integration with health technology assessment may improve timely and equitable access within SUS.
OBJECTIVES: To compare oncology drug approvals by the FDA, EMA, and ANVISA from 2020 to 2024, analyzing regulatory timelines, innovation profiles, therapeutic trends, and the interval between approval and incorporation into Brazil's Unified Health System (SUS).
METHODS: A retrospective study was conducted using publicly available data from the FDA, EMA, ANVISA, and the National Commission for Health Technology Incorporation (CONITEC). All first-time oncology drug approvals during the period were included. Approval dates, developer origin, exclusivity status, and time to potential SUS incorporation were assessed.
RESULTS: The FDA granted 73 approvals, followed by the EMA (56) and ANVISA (18). Regulatory convergence was high between the FDA and EMA, whereas ANVISA showed median approval delays of 353 days compared with the FDA and 336 days compared with the EMA. Relatively balanced distribution between biological and synthetic medicines was observed, with approvals concentrated among US-headquartered companies and primarily indicated for lung cancer, multiple myeloma, and breast cancer. FDA and EMA decisions relied on a more heterogeneous mix of trial phases and designs, whereas ANVISA more frequently required phase 3 randomized studies. Incorporation into SUS remained limited.
CONCLUSION: Greater integration between regulatory evaluation and health technology assessment is needed to reduce asymmetries and improve timely access to oncological innovations within SUS.
POLICY SUMMARY: Differences in oncology drug approvals across regulatory agencies contribute to delays in access to innovative cancer therapies in Brazil. Strengthening regulatory alignment and integration with health technology assessment may improve timely and equitable access within SUS.