OncoGenex Prostate Cancer Drug Gets Special FDA Review
Tue, 10/06/2009 - 4:34am
BOTHELL, Wash. (AP) — OncoGenex Pharmaceuticals Inc. said Tuesday the FDA granted a faster review process for the company's prostate cancer drug. The agency granted OGX-011, in combination with the chemotherapy treatment docetaxel, fast-track status as an initial treatment for progressive prostate cancer. That same drug combination already has fast-track status as a potential secondary treatment. The designation is given to developing treatments that could significantly help patients with serious or life-threatening conditions. A key feature of the review process is the ability of the company to submit study data as it becomes available, rather than all at once in a large filing. OGX-11 is moving into Phase III, or late-stage, development for prostate cancer.