OncoGenex Drug Gains Additional Fast Track Designation

OncoGenex Pharmaceuticals, Inc. received an additional Fast Track Designation from the FDA for OGX-011 (custirsen sodium) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment. OGX-011 previously received Fast Track for second-line docetaxel treatment for progressive metastatic prostate cancer following docetaxel.

Fast Track Designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. It was based on data from a randomized, Phase II study that suggested OGX-011 in combination with first-line docetaxel treatment may improve survival in patients with castrate resistant prostate cancer (CRPC).

“An expansion of the current Fast Track Designation to include OGX-011 in combination with first-line docetaxel treatment is consistent with our current development plans in prostate cancer,” said Scott Cormack, chief executive officer of OncoGenex. “We intend to execute Phase III trials, which now have completed Special Protocol Assessments for first-line and second-line chemotherapy treatment, and these Fast Track Designations along with the SPA’s should help us move expeditiously toward commercialization of OGX-011 in prostate cancer.”