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Rolling NDA Submitted to FDA for Satraplatin/Prednisone Combination in Hormone-Refractory Prostate Cancer
"I am very pleased to announce this latest milestone in the development of satraplatin as a potential new treatment option for patients suffering from hormone refractory prostate cancer," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. "In December alone, we achieved our target enrollment in the Phase 3 registrational trial, announced the opening of accrual of a Phase 2 study evaluating satraplatin in combination with Taxol(R) (paclitaxel) and reported that the independent Data Monitoring Board reviewed the safety data from the Phase 3 trial and recommended that the trial continue as planned. The submission of the rolling NDA is major step forward towards the ultimate goal of making satraplatin available to patients as quickly as possible."
The rolling submission process enables companies that have been granted "fast track" designation by the FDA 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. Under U.S. regulations, within sixty days after the receipt of such a submission, the FDA will determine whether that application may be filed. The filing of an application means that the FDA has determined that the application is sufficiently complete to permit a substantive review.
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 FDA granted fast track designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003.
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.
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 Phase 1 and Phase 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Further information on satraplatin can be found at the Company's website at www.spectrumpharm.com or in the Anticancer Programs section of GPC Biotech's website at www.gpc-biotech.com.
Source: Spectrum Pharmaceuticals, Inc.