FDA Grants Additional Fast Track Designation for OGX-011 in Combination with First Line Chemotherapy

09-Oct-2009 - USA

OncoGenex Pharmaceuticals, Inc. announced that OGX-011, also known as custirsen sodium, received an additional Fast Track Designation from the U.S. food & Drug Administration (FDA) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment. OncoGenex had previously received Fast Track Designation for second-line docetaxel treatment with OGX-011 in combination with docetaxel for treatment of progressive metastatic prostate cancer following docetaxel.

"An expansion of the current Fast Track Designation to include OGX-011 in combination with first-line docetaxel treatment, in addition to second-line docetaxel treatment of patients with progressive metastatic prostate cancer, is consistent with our current development plans in prostate cancer," said Scott Cormack, Chief Executive Officer of OncoGenex Pharmaceuticals. "We intend to execute Phase 3 clinical trial protocols, which now have completed Special Protocol Assessments (SPA's) 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."

The request for Fast Track designation was based on data from the randomized, Phase 2 study (Study OGX-011-03) that suggested OGX-011 in combination with first-line docetaxel treatment may improve survival in patients with castrate resistant prostate cancer (CRPC). The median overall survival in patients with CRPC who were treated with OGX-011 plus first-line docetaxel was 23.8 months (95% Confidence Interval (CI) from 16.2 to infinity) compared to 16.9 months (95% CI from 12.8 to 25.8) for patients treated with docetaxel alone with a hazard ratio of 0.61 (95% CI from 0.36 to 1.02).

https://www.bionity.com/en/news/107612/fda-grants-additional-fast-track-designation-for-ogx-011-in-combination-with-first-line-chemotherapy.html