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news.Pharmion Corporation has submitted a marketing authorization application with the European Medicines Agency for Thalidomide Pharmion for the treatment of skin cancer.
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The marketing application is for the use of Thalidomide Pharmion in untreated multiple myeloma patients. Thalidomide Pharmion has been designated as an orphan medicinal product in the EU.
The application is based upon a clinical data package comprised of four studies. In one of the studies there was an unprecedented 21-month survival advantage demonstrated for the Thalidomide arm. Pharmion believes Thalidomide, melphalan and prednisone should rapidly become the reference therapy for this patient population.
“Our data demonstrate significant benefit when Thalidomide is added to today's standard of care in untreated elderly patients with multiple myeloma,” said Philippe Moreau, professor of Clinical Hematology at Nantes Faculty of Medicine.
The company is seeking approval for Thalidomide Pharmion in combination with melphalan and prednisone for patients with untreated multiple myeloma aged 65 years or older or ineligible for high dose chemotherapy.
Pharmion is also seeking approval for Thalidomide Pharmion in combination with dexamethasone for induction therapy prior to high dose chemotherapy and bone marrow transplant, for patients with untreated multiple myeloma.