GPC Biotech’s New Drug Application for satraplatin plus prednisone for patients with hormone-refractory prostrate cancer who have not responded to chemotherapy has been given priority review status by the US Food and Drug Administration.
Earlier this year, the firm presented the third and final portion of its NDA - the clinical section - which was primarily based on data from the SPARC Phase III trial which involved 950 patients and showed highly statistically-significant results for prolonging progression-free survival.
“With the designation of priority review, we expect an action on the application from the FDA in August of this year and are thus moving forward with commercialisation plans for satraplatin,” said Dr Bernd R Seizinger, GPC Biotech’s chief executive officer. “If approved, we believe that satraplatin has the potential to become an important therapy for hormone-refractory prostate cancer patients whose disease has progressed after prior chemotherapy.”
Satraplatin is a member of the platinum family of compounds that form a critical part of modern chemotherapy treatments for a wide variety of cancers. The major advantage of satraplatin is that, unlike the current platinum therapies which are all administered intravenously, it is an orally bioavailable compound in capsule form that patients can take at home.
European filing expected in Q2
GPC Biotech has a co-development and license agreement with Pharmion, a wholly-owned subsidiary of Pharmion Corp, under which Pharmion has been granted exclusive commercialisation rights to satraplatin for Europe and certain other territories. Pharmion expects to complete the Marketing Authorisation Application for satraplatin for Europe in the second quarter of 2007.