GPC Biotech AG announced that it has withdrawn the satraplatin capsules New Drug Application (NDA) filed for accelerated approval for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.
The company based its decision on the vote by the Oncologic Drugs Advisory Committee (ODAC) to the US Food and Drug Administration (FDA) on July 24, 2007 that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether satraplatin is approvable.
The company anticipates overall survival results from the SPARC trial to be available within six months. However, this timing is based on an extrapolation of death rates in the trial and may change.
"While we were very surprised and disappointed by last week's ODAC outcome, we need to move forward," said Bernd R. Seizinger, M.D., Ph.D., chief executive officer of GPC Biotech. "Thus, we are focusing our efforts on the overall survival results from the satraplatin SPARC trial and integrating these data into the strongest possible NDA submission. If these data are positive, we plan to submit an NDA to the FDA as quickly as possible."
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority, and no conclusions can or should be drawn regarding its safety and efficacy.
A phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer whose prior chemotherapy has failed. Patients who have not progressed continue to be treated and all patients are being followed for overall survival. In July 2007, ODAC recommended that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether satraplatin is approvable.
GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech has also entered into an agreement with Yakult Honsha Co. Ltd. under which Yakult has been granted exclusive commercialization rights to satraplatin for Japan. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate satraplatin is currently in a phase 3 registrational trial in second-line hormone-refractory prostate cancer.