Posted by Michael Wonder on 18 Sep 2024
Oncology accelerated approvals are often based on non-comparative trials evaluating response rate
17 September 2024 - Most oncology products granted accelerated approval by the US FDA tend to rely on non-comparative single or multi-arm trials that use response rate as a primary outcome, according to recent research published in the Journal of Pharmaceutical Innovation.
Satoshi Kato and Shunsuke Ono, of the laboratory of pharmaceutical regulatory science at The University of Tokyo, said there were “considerable variations” in the requirements for post-accelerated approval requirements as well as flexibility in how FDA determined a product’s path to full approval.
