A novel endpoint for a cancer drug’s accelerated approval is more likely to get the go ahead from the US Food and Drug Administration if the sponsor has a fully accrued post-marketing study underway at the time of application, Oncology Center of Excellence Deputy Director Paul Kluetz said.
Kluetz noted this is one way in which an Oncology Center of Excellence project can help “de-risk” aspects of a...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?