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news.Pharmion Corporation has revealed plans to seek European marketing authorization for satraplatin, its drug candidate for the treatment of second-line hormone refractory prostate cancer, at the start of 2007.
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The timescale for the drug submission was announced after the European Medicines Authority informed the company that it would accept the final analysis for progression-free survival from the SPARC trial and the available overall survival data as the basis for the submission.
Pharmion Corporation licensed the European and certain other international marketing rights to satraplatin, the only oral platinum-based compound in advanced clinical development, from GPC Biotech in December 2005.
The companies are seeking an initial application in second line chemotherapy of HRPC and are exploring the potential for satraplatin in a wide range of additional indications.
“We are pleased to have agreement with the EMEA on our filing strategy for satraplatin,” said Patrick Mahaffy, Pharmion’s president and CEO. “We are committed to providing the submission to the EMEA in as timely a fashion as possible, pending the results from a final analysis of PFS in the SPARC study which we anticipate in the second half of 2006.”