SatraplatinTreatment for Prostate Cancer
Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer
Satraplatin NDA to be Reviewed by ODAC Panel on July 24, 2007
IRVINE, Calif., May 15, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced that on July 24, 2007 the Oncology Drug Advisory Committee (ODAC) will review the New Drug Application (NDA) for satraplatin, the Company's investigational drug for the second-line treatment of hormone refractory prostate cancer. The Oncology Drug Advisory Committee is an independent panel of experts who review the safety and efficacy of new cancer therapeutics and make recommendations for licensure to the Center for Drug Evaluation and Review Division of Oncology Drug Products. Although the committee provides advice to the agency and suggests a course of action, the United States Food and Drug Administration (FDA) is not obligated to follow that advice. The FDA makes the final decision regarding action on an NDA and market authorization.
During an ODAC meeting, committee members evaluate presentations made by the pharmaceutical sponsor of the drug under review, FDA review staff, and occasionally third-party oncology experts in an open forum. Following the presentations and the open public hearing, the committee members discuss questions drafted by the Agency staff on issues including study design, methodology, adequacy of data, assessment and interpretation of risk and benefit, and the meeting concludes with the committee providing recommendations.
"We are pleased at the opportunity to present satraplatin data to ODAC, as the ODAC presentation is a very important step in the NDA review process," said Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. "We have confidence in the clinical and statistical robustness of the study data and we remain optimistic regarding the potential for a favorable outcome. If ODAC agrees, and the FDA ultimately approves satraplatin, satraplatin will be the only approved drug for hormone refractory prostate cancer patients in the second-line setting. We believe the convenience to the patient of oral dosing and the favorable tolerability will also offer an advantage."
The NDA submission, per the terms of a Special Protocol Assessment, is based on a primary endpoint of an improvement in progression free survival (PFS) that was observed in the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial, a multi-center, randomized, double-blind, placebo-controlled Phase 3 study.
The NDA was submitted to FDA on February 15, 2007, accepted on April 16, 2007, and granted priority review status. The FDA grants priority review status to products that, if approved, would address an unmet medical need or are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. A Prescription Drug User Fee Act (PDUFA) action date of August 15, 2007 has been established by the FDA for a decision regarding the approval of the satraplatin application. Under the PDUFA goal, the FDA would either issue a complete response letter or approval by this date.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. According to the American Cancer Society, approximately 219,000 men in the U.S. are expected to be diagnosed and over 27,000 men are expected to die from the disease in 2007. In the European Union, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured or enter long-term remission. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells may become resistant to the hormones -- or "hormone refractory" -- and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for hormone-refractory prostate cancer. However, it is not a cure, and so this is creating a need for effective therapeutic options for these patients once they have progressed or relapsed.
Satraplatin, a fourth-generation, oral 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 oral compound and is given as capsules that patients can take at home.
In addition to hormone refractory prostate cancer, 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 chemotherapy and in a number of cancer types are underway or planned.
In 2002, Spectrum licensed the global rights to GPC Biotech . GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. 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.
Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and risk-reduced methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.
Forward-looking statement -- This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, our team's ability to identify promising drugs and move these drugs through development and toward commercialization, the potential for a favorable outcome for the NDA for satraplatin, that the convenience to the patient of oral dosing and the favorable tolerability will offer an advantage, that trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer chemotherapy and in a number of cancer types are underway or planned and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
CONTACT: Media, Russell Skibsted, SVP & Chief Business Officer, or PaulArndt, Manager, Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals, Inc.; or Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Ticker Symbol: (NASDAQ-NMS:SPPI),(NASDAQ-NMS:GPCB)
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Posted: May 2007
- 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
- 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
- GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin - December 15, 2005