OncoGenex has received an additional Fast Track Designation from FDA for OGX-011 (also known as custirsen sodium) for progressive metastatic prostate cancer, in combination with first-line docetaxel treatment.
Reportedly, 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.
The company said that the request for Fast Track designation was based on data from the randomised, phase 2 study (Study OGX-011-03) It suggested that 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).
Scott Cormack, CEO of OncoGenex, said: “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.
“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 toward commercialisation of OGX-011 in prostate cancer.”