Yes approval was almost two months early. The NDA was submitted December 20 so the PDUFA date would have June 20.
Approval is for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy -- essentially the same population as in the OGX-011 P3 pain palliation trial. I'm less worried than I used to be that abiraterone's approval will slow enrollment in that trial as patients opt to try abiraterone instead of undergoing a second round of chemo. Cormack has persuaded me in recent conference calls that bone pain is a huge issue in this population so a trial that's designed to test OGX-011's ability to reduce it shouldn't have too much trouble attracting patients. According to clinicaltrials.gov, virtually all the trial sites in the U.S. and Canada are recruiting, so hopefully they're reasonably far along. (No mention there of any European trial sites, even though in a PR dated February 25, 2010 OGXI said it planned to expand the trial to Europe.)
I also dont think enrollment will be an issue. One interesting statistics of the abiraterone trial is that 30% of the patients had two prior docetaxel regimens. So we might learn more about this subset later.
Also, while reading it, to my surprise, I found the following warning (page 9) (although very rare. woman can get prostate cancer)
ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the potential risk for pregnancy loss. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with ZYTIGA.