Cancer therapy approval timings in the US and Europe, 2010-2019

Ensuring patients have access to safe and efficacious cancer medicines in a timely manner is an essential goal for regulatory agencies. A cross-sectional study compared market authorization dates for new oncology therapies approved in the US and Europe over the past decade. The study found that the FDA approved 85 of 89 oncology therapies (95%) before the EMA did. The median delay in market authorization for new oncology therapies in Europe was 241 days compared with the US. The median review time was 200 days versus 426 days. Thirty-five therapies (39%) were approved by the FDA prior to pivotal study publication, versus only 8 (9%) by the EMA.