Overall Survival Is Not A Required Primary Endpoint In All Cancer Trials, US FDA Says

25 Apr 2024

Seeking to clear up a ‘misconception,’ Oncology Center of Excellence officials say earlier endpoints, such as progression-free survival and overall response, continue to be useful in getting therapies to market quicker, but sponsors still should plan to systematically collect OS data to ensure there is no detriment to survival.

Gold standard — Overall survival remains the gold standard endpoint, but need not be the primary analysis in every study. • Source: Shutterstock

The US Food and Drug Administration’s cancer office wants sponsors to know that overall survival is not always a required primary endpoint in oncology clinical trials.

However, the agency still wants overall survival data collected in a systematic, comprehensive way to provide a check on a...