A RECENT study has spotlighted the regulatory divide between the US Food and Drug Administration’s (FDA) Accelerated Approval (AA) pathway and the European Medicines Agency’s (EMA) Conditional Marketing Authorization (CMA) process, showing stark differences in their cancer drug approvals. The study found that only 43% of US cancer drugs granted accelerated approval since 2015 were subsequently authorized by the EMA, and many remain unapproved in the European Union (EU) 5 years post-approval in the US.
The researchers focused on cancer indications specifically because of the heightened need for rapid intervention. The latest findings revealed that 57% of these drugs have yet to demonstrate a clinical benefit, despite being available on the US market for more than 5 years. The study raises concerns among EU regulators who have withheld approval until more robust evidence can demonstrate therapeutic benefit.
In comparison, the EU’s CMA approach maintains strict evidence standards even for drugs that address unmet medical needs, reflecting a more cautious approach that potentially prioritizes patient safety over swift market entry.
Reference: Studsgaard Petersen T et al. Regulatory fate of cancer indications in the european union after accelerated approval in the US. JAMA Oncol. doi:10.1001/jamaoncol.2024.5145.
