Janssen files for expanded use of Velcade in EU patients
- Janssen has filed to expand use of Velcade (bortezomib) from treatment of patients with multiple myeloma, to now also include patients with mantle cell lymphoma (MCL)
- MCL is a rare blood disease that usually occurs in older people.
- Janssen has tested Velcade in patients with MCL and had positive results in phase III trials. Velcade is intended to be used as part of combination therapy.
Velcade is a proteosome inhibitor that has shown efficacy in clinical trials for the treatment of MCL. In a phase III, randomized trial, Velcade combined with melphalan and prednisone (VR-CAP) was compared with standard of care---a combination of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP). VR-CAP significantly increased progression-free survival (PFS). Based on analysis from an independent review committee, there was a 59% increase in median PFS (27.4 vs. 14.4 months); however, the investigators documented a 96% increase in median PFS (30.7 vs 16.1 months). Although VR-CAP was associated with a higher rate of side effects and adverse events, mainly thrombocytopenia and infection, Janssen concluded that the overall results were compelling enough to file for the expanded indication.
- www.firstwordpharma.com Janssen Submits Eu Marketing Application For Velcade (Bortezomib) In Mantle Cell Lymphoma