- Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA).
- France has implemented the ATU (Temporary Authorization for Use) program to facilitate earlier access to therapeutic innovations, allowing drug administration prior to European Medicines Agency (EMA) approval.
- The study compares the average time for accessing anti-neoplastic drugs globally, considering ATU, FDA, and EMA approvals.
- From 2007 to 2019, 36 out of 64 oncology drugs with MA used the ATU system, benefiting 16,927 patients. The ATU enabled earlier access to 25 of these drugs, on average 203 days before FDA and 428 days before EMA approvals.
- Only 3 of the 36 drugs received EMA approval before FDA approval, with an average delay of 216 days between European MA and FDA approval.
- The ATU system ensures full healthcare coverage for patients receiving therapeutic innovations before official MA in Europe and the USA.