The submission is based upon data from the phase III SPARC trial comparing satraplatin plus prednisone to placebo plus prednisone in 950 patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed. The disease affects approximately 80,000 men in the EU.
“Data from the SPARC trial demonstrate that satraplatin lowers the risk of disease progression or death by 33% compared to control, including for patients previously treated with docetaxel chemotherapy,” said Cora Sternberg, chief of the Department of Medical Oncology at the San Camillo Forlanini Hospital in Rome, and one of the principal investigators of the trial.
“These encouraging results, together with satraplatin’s manageable side effect profile, suggest that Satraplatin represents an important new therapy option for patients with advanced prostate cancer whose prior chemotherapy has failed.”
Pharmion has a co-development and license agreement with GPC Biotech, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech submitted a NDA for satraplatin to the FDA earlier this year, which has been accepted for priority review.