Aptose Biosciences Inc (APTO)

[dcaf7]

It should affect Aptose. After that, don't think FDA will allow them to run a single arm combo trial. Possibly, even Tusp single arm monotherapy trial is in question.
Mar 24, 2023
US FDA proposes higher bar for accelerated approvals for cancer drugs.
Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly but have been criticized because some drugs have later been proven to be ineffective.
The FDA proposed that companies conduct randomized controlled trials in which patients receive either a therapy or another alternate treatment instead of trials that test the drug without a comparator, known as single-arm studies.
Single-arm studies can be conducted in some cases, but those need to be discussed with the agency beforehand, it said.
"Given the limitations of single-arm trials, a randomized controlled trial is the preferred approach to support an application for accelerated approval," the FDA said.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-seeks-more-rigorous-trials-cancer-drugs-accelerated-nod-2023-03-24/