Vielleicht werden die Ami`s wach!? **************************************************
GPC Biotech/Pharmion: satraplatin edges closer to approval 27th June 2007 By Tom Gray European marketing application submitted for novel prostate cancer chemotherapy. GPC Biotech's partner, Pharmion, has submitted a European marketing application for satraplatin in combination with prednisone for the second-line treatment of hormone refractory prostate cancer (HRPC). A Phase III trial has indicated the efficacy of this drug combination in HRPC, where unmet need is high. Approval of this combination and significant physician uptake is therefore likely. 'Content A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) for GPC Biotech/Pharmion's satraplatin in combination with prednisone for the second-line treatment of HRPC. This application follows the New Drug Application (NDA) submitted to the FDA in February 2007, which was granted priority review status in April 2007.
Advertisement Satraplatin is an orally administered platinum-based cytotoxic therapy which is also in development for other tumor types. The drug was licensed to GPC Biotech by NeoOncoRx (a subsidiary of Spectrum Pharmaceuticals) in October 2002.
Prostate cancer has a very high prevalence, with an annual incidence of around 400,000 across the seven major markets. A significant proportion of prostate cancer patients (around 40%) go on to develop HRPC, the form of the disease that is resistant to antihormonal therapies. Of this subset of patients, the majority will move on to a second-line chemotherapy following first-line treatment. Given the lack of effective second-line chemotherapies for HRPC, there is considerable unmet need for this large group of patients.
The MAA is supported by data from a Phase III trial which were presented at this year's meeting of the American Society of Clinical Oncology. In the randomized double-blinded trial, known as SPARC, 950 patients were divided into two treatment arms and administered with either satraplatin and prednisone or a placebo and prednisone.
A 35% reduction in the risk of disease progression and a 33% reduction in the risk of pain progression was observed in patients who received satraplatin, while 7% of patients in the satraplatin arm showed an objective tumor response, compared to just 1% in the placebo arm. In terms of side effects, the combination of satraplatin and prednisone was reported to be well tolerated.
Based on these data - coupled with significant unmet need in HRPC and satraplatin's favorable route of administration - the drug combination has a good chance of receiving approval from the EMEAand the FDA. If the drug combination is approved, it is likely that physician uptake will be high because of the lack of effective second-line chemotherapies for HRPC. Satraplatin can therefore be expected to gain a considerable share of this relatively large market.
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