{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T03:22:03Z","timestamp":1778901723073,"version":"3.51.4"},"reference-count":31,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T00:00:00Z","timestamp":1722556800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Current Oncology"],"abstract":"<jats:p>Introduction: Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Brazilian Health Regulatory Agency (ANVISA) since 2008. Methods: Data were collected from public and online databases by searching for the date of submission, the date of the procedure, the date of approval, clinical indication, and drug characteristics. The distribution was tested using the Shapiro\u2013Wilk, test and comparisons were made using the Mann\u2013Whitney U test; the data are reported using median days and interquartile range (IQR1\u2013IQR3). Results: In total, 104 new oncologic drugs for the treatment of solid tumors were approved by the three agencies: 98 by the FDA, 90 by the EMA, and 68 by ANVISA. The cancer types with the highest number of first indications were lung cancer (n = 24), breast cancer (n = 15), and melanoma (n = 15). Most approvals were for oral medications (n = 63) and tyrosine\u2013kinase inhibitors or other small-molecule inhibitors (n = 54). Time to approval after submission was as follows: the FDA\u2014224 days (167\u2013285); the EMA\u2014364 days (330\u2013418); and ANVISA\u2014403 days (276\u2013636) (p &lt; 0.00001 for the FDA to the EMA and the FDA to ANVISA). The difference between submission dates among the agencies was as follows: EMA\u2013FDA: 24 days (0\u201385); ANVISA\u2013FDA: 255 (114\u2013632); and ANVISA\u2013EMA: 260 (109\u2013645). The difference in approval dates between the agencies was as follows: EMA\u2013FDA: 185 days (59\u2013319); ANVISA\u2013FDA: 558 (278\u2013957); and ANVISA\u2013EMA: 435 days (158\u2013918). Conclusions: New oncologic drugs are submitted to the FDA and EMA for approval on similar dates; however, the longer appraisal period by the EMA pushes the approval date for Europe to approximately 6 months later. The same steps at ANVISA delay the approval by 1.5 years. Such procedures cause a significant difference in available medications between these regions.<\/jats:p>","DOI":"10.3390\/curroncol31080332","type":"journal-article","created":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T15:24:16Z","timestamp":1722957856000},"page":"4443-4454","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["New Oncologic Drugs from 2008 to 2023\u2014Differences in Approval and Access between the United States, Europe and Brazil"],"prefix":"10.3390","volume":"31","author":[{"given":"Rafael Balsini","family":"Barreto","sequence":"first","affiliation":[{"name":"Centro de Pesquisa Oncol\u00f3gicas\u2014CEPON, Rodovia Admar Gonzada, 655, Florian\u00f3polis 88034-000, SC, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andressa Moretti","family":"Izidoro","sequence":"additional","affiliation":[{"name":"Centro de Pesquisa Oncol\u00f3gicas\u2014CEPON, Rodovia Admar Gonzada, 655, Florian\u00f3polis 88034-000, SC, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario Henrique Furlanetto","family":"Miranda","sequence":"additional","affiliation":[{"name":"Centro de Pesquisa Oncol\u00f3gicas\u2014CEPON, Rodovia Admar Gonzada, 655, Florian\u00f3polis 88034-000, SC, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,8,2]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1038\/s41571-019-0313-2","article-title":"New drug approvals in oncology","volume":"17","author":"Kurzrock","year":"2020","journal-title":"Nat. Rev. Clin. Oncol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"m3434","DOI":"10.1136\/bmj.m3434","article-title":"Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: Retrospective cohort study","volume":"371","author":"Hwang","year":"2020","journal-title":"BMJ"},{"key":"ref_3","unstructured":"(2024, April 22). Novel Drug Approvals at FDA, Available online: https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/drug-approvals-and-databases."},{"key":"ref_4","unstructured":"(2024, April 22). Medicine Evaluation Figures. Available online: https:\/\/www.ema.europa.eu\/en\/about-us\/what-we-do\/authorisation-medicines\/medicine-evaluation-figures."},{"key":"ref_5","unstructured":"(2024, April 22). Novos Medicamentos e Indica\u00e7\u00f5es, Available online: https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/medicamentos\/novos-medicamentos-e-indicacoes."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1236","DOI":"10.1016\/j.drudis.2021.12.021","article-title":"An overview of cancer drugs approved through expedited approval programs and orphan medicine designation globally between 2011 and 2020","volume":"27","author":"Wang","year":"2022","journal-title":"Drug Discov. Today"},{"key":"ref_7","unstructured":"(2024, April 22). Brazilian Law #13411 from December 28th, 2016, Available online: https:\/\/www.planalto.gov.br\/ccivil_03\/_ato2015-2018\/2016\/lei\/l13411.htm."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"6412","DOI":"10.1158\/1078-0432.CCR-20-3292","article-title":"Project Orbis: Global Collaborative Review Program","volume":"26","author":"Spillman","year":"2020","journal-title":"Clin. Cancer Res."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"m4087","DOI":"10.1136\/bmj.m4087","article-title":"Mortality due to cancer treatment delay: Systematic review and meta-analysis","volume":"371","author":"Hanna","year":"2020","journal-title":"BMJ"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1007\/s40487-022-00187-3","article-title":"Estimating the Impact of Delayed Access to Oncology Drugs on Patient Outcomes in Canada","volume":"10","author":"Erim","year":"2022","journal-title":"Oncol. Ther."},{"key":"ref_11","unstructured":"(2024, July 23). Annual Reports and Work Programmes. Available online: https:\/\/www.ema.europa.eu\/en\/about-us\/annual-reports-work-programmes."},{"key":"ref_12","unstructured":"(2024, July 23). Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals, Available online: https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals."},{"key":"ref_13","unstructured":"(2024, July 23). Consultas, Available online: https:\/\/consultas.anvisa.gov.br\/#\/medicamentos\/."},{"key":"ref_14","unstructured":"(2024, July 23). Drugs@FDA: FDA-Approved Drugs, Available online: https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm."},{"key":"ref_15","unstructured":"(2024, July 23). Medicines. Available online: https:\/\/www.ema.europa.eu\/en\/medicines."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"849","DOI":"10.1001\/jamaoncol.2017.5618","article-title":"A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review","volume":"4","author":"Beaver","year":"2018","journal-title":"JAMA Oncol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"h4633","DOI":"10.1136\/bmj.h4633","article-title":"Trends in utilization of FDA expedited drug development and approval programs, 1987\u20132014: Cohort study","volume":"351","author":"Kesselheim","year":"2015","journal-title":"BMJ"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"e126","DOI":"10.1016\/S1470-2045(23)00592-2","article-title":"Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications","volume":"25","author":"Koole","year":"2024","journal-title":"Lancet Oncol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1001\/jama.2017.9415","article-title":"Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration","volume":"318","author":"Naci","year":"2017","journal-title":"JAMA"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1304","DOI":"10.1158\/1055-9965.EPI-19-1534","article-title":"Medical Care Costs Associated with Cancer Survivorship in the United States","volume":"29","author":"Mariotto","year":"2020","journal-title":"Cancer Epidemiol. Biomark. Prev."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"906","DOI":"10.1001\/jamainternmed.2019.0462","article-title":"Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval","volume":"179","author":"Gyawali","year":"2019","journal-title":"JAMA Intern. Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"4398","DOI":"10.1200\/JCO.2008.21.1961","article-title":"Accelerated approval of cancer drugs: Improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?","volume":"27","author":"Richey","year":"2009","journal-title":"J. Clin. Oncol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1453","DOI":"10.1377\/hlthaff.2014.0122","article-title":"Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals","volume":"33","author":"Frank","year":"2014","journal-title":"Health Aff. (Millwood)"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1186\/s41120-018-0029-x","article-title":"ANVISA: An introduction to a new regulatory agency with many challenges","volume":"4","year":"2018","journal-title":"AAPS Open"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1428","DOI":"10.1007\/s43441-020-00169-5","article-title":"A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013\u20132016","volume":"54","author":"Patel","year":"2020","journal-title":"Ther. Innov. Regul. Sci."},{"key":"ref_26","unstructured":"(2024, April 22). Resolu\u00e7\u00e3o de Diretoria Colegiada da ANVISA #204, 2017, Available online: http:\/\/antigo.anvisa.gov.br\/documents\/10181\/2718376\/RDC_204_2017_.pdf."},{"key":"ref_27","unstructured":"(2024, April 22). Resolu\u00e7\u00e3o de Diretoria Colegiada da ANVISA #205, 2017, Available online: https:\/\/bvsms.saude.gov.br\/bvs\/saudelegis\/anvisa\/2017\/rdc0205_28_12_2017.pdf."},{"key":"ref_28","unstructured":"(2024, April 22). Orienta\u00e7\u00e3o de Servi\u00e7o n\u00b0 45 de 2018\u2014ANVISA, Available online: https:\/\/web.archive.org\/web\/20180903055715\/http:\/\/portal.anvisa.gov.br\/documents\/33836\/4095801\/Orienta%C3%A7%C3%A3o%2Bde%2Bservi%C3%A7o%2Bn%C2%BA%2B45%2Bde%2B2018\/2bca930c-6a5a-4834-99e9-89fc5bc0debd."},{"key":"ref_29","unstructured":"(2024, April 22). Anvisa Divulga Resultados do Projeto Orbis, Available online: https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2024\/anvisa-divulga-resultados-do-projeto-orbis."},{"key":"ref_30","unstructured":"(2024, April 22). Contrato que Entre si Celebram a Uni\u00e3o, por Interm\u00e9dio do Departamento de Log\u00edstica em Sa\u00fade da Secretaria Executiva do Minist\u00e9rio da Sa\u00fade, e a Empresa Produtos Roche Qu\u00edmicos e Farmac\u00eauticos S.A, Available online: https:\/\/www.gov.br\/saude\/pt-br\/acesso-a-informacao\/licitacoes-e-contratos\/contratos-dlog\/dlog-2020\/no-contrato-219-2020\/view."},{"key":"ref_31","unstructured":"(2024, April 22). Pertuzumabe Para o Tratamento do C\u00e2ncer de Mama HER2-Positivo Metast\u00e1tico em Primeira Linha de Tratamento Associado ao Trastuzumabe e Docetaxel\u2014Relat\u00f3rio de Recomenda\u00e7\u00e3o, Available online: https:\/\/www.gov.br\/conitec\/pt-br\/midias\/relatorios\/2017\/relatorio_pertuzumabetrastuzumabe_ca_mama.pdf."}],"container-title":["Current Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1718-7729\/31\/8\/332\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T15:28:38Z","timestamp":1760110118000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1718-7729\/31\/8\/332"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,2]]},"references-count":31,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2024,8]]}},"alternative-id":["curroncol31080332"],"URL":"https:\/\/doi.org\/10.3390\/curroncol31080332","relation":{},"ISSN":["1718-7729"],"issn-type":[{"value":"1718-7729","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,2]]}}}