EMEA accepts Pharmion's Thalidomide MA

The European Medicines Agency (EMEA) has accepted for review US firm Pharmion Corp Marketing Authorization Application for Thalidomide Pharmion (thalidomide) for the treatment of untreated multiple myeloma that was submitted in January 2007. The application is based on a clinical data package comprised of four studies in more than 1,400 patients, including one that showed a 21-month survival advantage when Thalidomide was added to the standard of care.

"We believe that these data clearly demonstrate the value Thalidomide Pharmion provides patients with untreated multiple myeloma," said Patrick Mahaffy, the company's chief executive. "Based on these strong results, we believe that it is time that this widely used and critical therapy come under regulatory oversight to ensure equal and regulated access to its benefits throughout Europe," he added.

The firm is seeking authorization for the following indications: 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; and 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.