European Commission Approves Frontline Induction Therapy before Stem Cell Transplantation
News Aug 09, 2013
Janssen-Cilag International NV (Janssen) announced that the European Commission (EC) has approved the use of VELCADE® (bortezomib) as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD).1 This licence 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 (bortezomib) 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.2 Multiple myeloma, a type of blood cancer, currently affects around 60,000 people in Europe.3 This decision could mean significantly improved outcomes for many patients with this disease.
The approval by the EC was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM05) which demonstrated that treatment with VELCADE-based induction resulted in improvements in post-induction and post-transplant response rates and in progression-free survival (PFS); PFS and overall survival (OS) were secondary endpoints.
The trials studied the use of VELCADE-based regimens VD and VTD, compared to non-VELCADE-based regimens of vincristine plus doxorubicin and dexamethasone, or thalidomide and dexamethasone, respectively, as induction therapy prior to autologous stem cell transplant in adult patients with previously-untreated multiple myeloma.
Scleroderma Study Offers New Hope For SufferersNews
An unusual autoimmune disease that causes skin and lung damage can be treated effectively by stem cell transplant, a new study found. The approach could represent the first new treatment to improve survival in patients with severe scleroderma in more than four decades.READ MORE
Heart-muscle Patches Created from Human Cells Improve Recovery from Heart AttacksNews
Large, human cardiac-muscle patches created in the lab have been tested, for the first time, on large animals in a heart attack model. This clinically relevant approach showed that the patches significantly improved recovery from heart attack injury.READ MORE