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Oncologic Drugs Advisory Committee Recommends That FDA Should Wait for Overall Survival Analysis of Satraplatin
"We have confidence the final data analysis of overall survival will demonstrate the efficacy and safety of satraplatin for the treatment of hormone-refractory prostate cancer," said Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals.
"We will continue to advance our late stage, value-driving pipeline which includes ongoing Phase 3 trials for EOquin(R) for the treatment of non- invasive bladder cancer which is rapidly accruing patients," said Rajesh C. Shrotriya, M.D. Spectrum's Chairman, President, and Chief Executive Officer. "We are also planning to begin a Phase 3 trial of ozarelix for benign prostate hypertrophy by the end of the year."
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 with the disease in 2007 and over 27,000 men are expected to die from the disease. In the Europe, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die. 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. For many others, though, the disease recurs. Recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells 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 HRPC. However, it is not a cure. Consequently, there is a growing need for effective therapeutic options, such as second-line chemotherapy treatments, for patients once they have progressed.
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. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.
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.
Source: Spectrum Pharmaceuticals