For Cancer Drugs With China-Only Data, US FDA Leaves Door Open Just A Crack
Regulatory flexibility may be warranted for diseases with low prevalence in the US, such as nasopharyngeal carcinoma, or for pediatric tumors, which are difficult to study in multi-regional trials, FDA officials said at the advisory committee review of Innovent/Lilly’s lung cancer drug sintilimab; the agency has no plans to change its regulations on evaluation of foreign clinical data.
You may also be interested in...
Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.
Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker