Raw Data.csvNew Oncologic Drugs from 2008 to 2023 - Differences in Approval and Access between the United States, Europe and Brazil

<strong>Abstract: </strong>[WG1] [rb2] [rb3] INTRODUCTION: Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective is to evaluate the approval of new oncological drugs for solid tumors since 2008 by the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Brazilian Health Regulatory Agency (ANVISA). METHODS: Data was collected from public and online databases searching for date of submission, date of procedure, date of approval, clinical indication and drug characteristics. Normal distribution was tested by the Shapiro-Wilk test, comparisons were made with the Mann-Whitney test and the data are reported using median days and interquartile range (IQR1-IQR3). RESULTS: One-hundred and four new oncologic drugs for solid tumors were approved by the three agencies, 98 by the FDA, 90 by the EMA and 68 for ANVISA. Diseases with the highest number of first indications were lung cancer (n=24), breast cancer (n=15) and melanoma (n=15). Most were oral medications (n=63) and tyrosine-kinase inhibitors or other small molecules inhibitors (n=54). Time to approval after submission: FDA - 224 days (167-285); EMA - 364 days (330-418); ANVISA - 403 days (276-636) (p&lt;0.00001 for FDA to EMA and FDA to ANVISA). Difference between submission dates: EMA-FDA: 24 days (0-85); ANVISA-FDA: 255 (114-632); ANVISA-EMA: 260 (109-645). Approval dates: EMA-FDA: 185 days (59-319); ANVISA-FDA: 558 (278-957); ANVISA-EMA: 435 days (158-918).  CONCLUSIONS: New oncologic drugs are submitted for approval at FDA and EMA at similar dates, but the longer appraisal period by EMA pushes the approval date at Europe to approximately 6 months later. The same steps at ANVISA delay the approval by 1.5 year. Such procedures cause a significant difference in available medications between these regions.