The application is based upon a clinical data package comprised of four studies, including a study that showed a 21-month survival advantage when Thalidomide was added to the standard of care.
Pharmion is seeking authorization for Thalidomide Pharmion in combination with melphalan and prednisone for the treatment of patients with untreated multiple myeloma aged 65 years or older or ineligible for high dose chemotherapy.
The company is also seeking approval for Thalidomide Pharmion in combination with dexamethasone for induction therapy prior to high dose chemotherapy and bone marrow transplant, for the treatment of patients with untreated multiple myeloma.
Thalidomide Pharmion has been designated as an orphan medicinal product in the EU for the treatment of multiple myeloma which entitles the drug to ten years of market exclusivity for the approved indications.
The company holds exclusive marketing and distribution rights from Celgene Corporation for Thalidomide in markets outside of North America, Japan and certain other Asian countries.