Janssen, Celgene receive EC approval for multiple myeloma
Two multiple myeloma drugs have been approved for use in Europe by the European Commission.
Janssen's Velcade (bortezomib) has been given an extended approval as an induction therapy in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD). This license extension will apply to adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.
Until now, Velcade's indication has been limited to its use, in combination with melphalan and prednisone, in adult patients with multiple myeloma that are previously untreated and ineligible for stem cell transplant, and as a single agent in advanced multiple myeloma.
The European Commission has also approved Celgene's new blood cancer drug pomalidomide for use in combination dexamethasone for adult patients with relapsed and refractory multiple myeloma who have demonstrated disease progression despite receiving at least two prior therapies, including both lenalidomide and bortezomib.
Following this announcement, Celegene plans to launch pomalidomide in Europe with the trade name of Imnovid.
"With today's approval, Celgene becomes one of the few companies to deliver treatments across all stages of multiple myeloma, right from the start at diagnosis."
Alan Colowick, president of Celgene in Europe, the Middle East and Africa.
Multiple myeloma currently affects approximately 60,000 people in Europe. It is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of abnormal plasma cells. It is the second most frequent form of malignant bone marrow diseases and is a relatively rare form of cancer that accounts for roughly one percent of all cancers and roughly two percent of all deaths from cancer.
The European Commission's decision about these two drugs could mean significantly improved outcomes for many patients with this disease.