SatraplatinTreatment for Prostate Cancer
GPC Biotech Submits Non-Clinical Section of Rolling NDA for Satraplatin
MARTINSRIED/MUNICH, Germany, July 12, 2006 -- WALTHAM, Mass. and PRINCETON, N.J. -- GPC Biotech AG today announced that the Company has submitted the non-clinical section of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). The Company submitted the chemistry, manufacturing and controls -- or CMC -- section of the NDA in December 2005 and anticipates completing the NDA submission by the end of 2006.
"The non-clinical section is the second of three parts necessary to complete the NDA submission. We are very pleased that we continue to make such good progress in advancing satraplatin toward the market and that we remain on track with our timelines," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "The second half of 2006 promises to be of seminal importance for GPC Biotech as we expect to have the final data on progression- free survival from our SPARC registrational trial in the fall and complete the NDA filing by the end of this year."
The FDA granted "fast track" designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003. The FDA's fast track programs are intended to expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.
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. 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.
In December 2005, GPC Biotech completed accrual to the SPARC trial that is evaluating satraplatin in combination with prednisone as second-line chemotherapy in patients with hormone refractory prostate cancer. Also in December 2005, GPC Biotech initiated the rolling submission of an NDA for satraplatin with the FDA. The Company 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.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
Posted: July 2006
- 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 Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin - December 15, 2005