Celgene International Sarl said that Thalidomide Pharmion has been granted full marketing authorisation by the European Commission for use in combination with melphalan and prednisone as a treatment for patients with newly diagnosed multiple myeloma.
In June 2007, the European Commission granted the company's Revlimid full marketing authorisation as the first oral treatment in more than 40 years for patients with multiple myeloma who have received at least one prior therapy. These approvals confirm the leading role of Celgene in blood cancer research and innovative oral therapies.
Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are more than 85,000 men and women in Europe currently undergoing treatment for multiple myeloma, and 25,000 people are expected to die from this blood cancer in 2008.
"The European Union authorization of Thalidomide Pharmion is an important and positive milestone for men and women newly diagnosed with multiple myeloma. When coupled with the approval of Revlimid and dexamethasone in 2007, Celgene is advancing its goal of delivering vital therapies to people in need worldwide," said Aart Brouwer, president, Celgene International. "We are working diligently with local regulatory authorities to determine next steps for pricing, reimbursement and distribution plans for all European Union member states so that Thalidomide Pharmion will be available for eligible patients as quickly as possible."
Thalomid (thalidomide) researched, developed and commercialised by Celgene Corporation, received US Food and Drug Administration (FDA) approval on May 25, 2006 as an oral treatment in combination with dexamethasone for patients newly diagnosed with multiple myeloma. In 2008, the Australian Drug Evaluation Committee (ADEC) granted Thalidomide Pharmion marketing approval for use in combination with melphalan and prednisone for patients with untreated multiple myeloma or ineligible for high dose chemotherapy. Additionally, Thalidomide Pharmion was granted marketing approval in combination with dexamethasone for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. In 2003, ADEC approved Thalidomide Pharmion, as a monotherapy, for treatment for patients with multiple myeloma after failure of standard therapies.
Thalomid received FDA clearance in 1998, and Thalidomide Pharmion received TGA approval, in 2003, for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.