Rafael Balsini Barreto, Andressa Moretti Izidoro, Mario Henrique Furlanetto Miranda
{"title":"New Oncologic Drugs from 2008 to 2023—Differences in Approval and Access between the United States, Europe and Brazil","authors":"Rafael Balsini Barreto, Andressa Moretti Izidoro, Mario Henrique Furlanetto Miranda","doi":"10.3390/curroncol31080332","DOIUrl":null,"url":null,"abstract":"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–Wilk, test and comparisons were made using the Mann–Whitney U test; the data are reported using median days and interquartile range (IQR1–IQR3). 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–kinase inhibitors or other small-molecule inhibitors (n = 54). Time to approval after submission was as follows: the FDA—224 days (167–285); the EMA—364 days (330–418); and ANVISA—403 days (276–636) (p < 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–FDA: 24 days (0–85); ANVISA–FDA: 255 (114–632); and ANVISA–EMA: 260 (109–645). The difference in approval dates between the agencies was as follows: EMA–FDA: 185 days (59–319); ANVISA–FDA: 558 (278–957); and ANVISA–EMA: 435 days (158–918). 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.","PeriodicalId":11012,"journal":{"name":"Current oncology","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/curroncol31080332","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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–Wilk, test and comparisons were made using the Mann–Whitney U test; the data are reported using median days and interquartile range (IQR1–IQR3). 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–kinase inhibitors or other small-molecule inhibitors (n = 54). Time to approval after submission was as follows: the FDA—224 days (167–285); the EMA—364 days (330–418); and ANVISA—403 days (276–636) (p < 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–FDA: 24 days (0–85); ANVISA–FDA: 255 (114–632); and ANVISA–EMA: 260 (109–645). The difference in approval dates between the agencies was as follows: EMA–FDA: 185 days (59–319); ANVISA–FDA: 558 (278–957); and ANVISA–EMA: 435 days (158–918). 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.
期刊介绍:
Current Oncology is a peer-reviewed, Canadian-based and internationally respected journal. Current Oncology represents a multidisciplinary medium encompassing health care workers in the field of cancer therapy in Canada to report upon and to review progress in the management of this disease.
We encourage submissions from all fields of cancer medicine, including radiation oncology, surgical oncology, medical oncology, pediatric oncology, pathology, and cancer rehabilitation and survivorship. Articles published in the journal typically contain information that is relevant directly to clinical oncology practice, and have clear potential for application to the current or future practice of cancer medicine.