SatraplatinTreatment for Prostate Cancer
GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Worldwide sales of these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Target enrollment has been achieved in a Phase 3 registrational trial - the SPARC trial - as a second-line chemotherapy treatment for HRPC. GPC Biotech has completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc.
Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other studies evaluating satraplatin in combination with other therapies and in various cancers, including breast and lung cancers, are underway or planned.
Posted: December 2005
- GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis - July 30, 2007
- Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer - July 25, 2007
- Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer - May 15, 2007
- FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status - April 16, 2007
- GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin - February 16, 2007
- GPC Biotech Submits Non-Clinical Section of Rolling NDA for Satraplatin - July 12, 2006