Posted by Michael Wonder on 05 Mar 2019
Moving upstream in anti-cancer drug development
4 March 2019 - The development of oncology drugs traditionally begins by studying them in heavily pretreated patients, and then working ‘upstream’ to populations with earlier-stage disease.
The recent FDA approval of an androgen receptor antagonist first in prostate cancer patients without demonstrable metastatic disease but at high-risk for metastasis, based on a novel metastasis-free survival end point developed by the FDA, could provide a template for a paradigm shift.
Traditionally, oncology drugs are first studied and approved in patients with advanced, heavily pretreated cancers, and then in patient populations with earlier stages of disease. This is an efficient route for bringing a new drug to patients for several reasons.
