Cancer drugmakers pursuing the FDA’s accelerated approval mechanism to sell their treatments more quickly should opt for randomized controlled trials instead of giving the experimental therapy to everyone.
The Food and Drug Administration announced Friday draft guidance on clinical trial considerations to support accelerated approval of oncology therapeutics.
Accelerated approval has come to the forefront after the controversy behind the approval of Biogen’s Alzheimer’s drug Aduhelm, but the cancer drug development space uses this mechanism most frequently. A JAMA Oncology study found 48 of the 66 oncology drugs approved between 2009 and 2022 came through the accelerated approval pathway. ...