Janssen-Cilag International NV (Janssen) has announced that the European Commission has granted marketing authorisation for the subcutaneous (under the skin) administration of VELCADE® (bortezomib) in the European Union. Bortezomib is indicated for the treatment of multiple myeloma, a type of blood cancer.(1) The authorisation is based on data from a Phase III study demonstrating that subcutaneous administration of bortezomib is equally effective as intravenous (into the vein) bortezomib but is associated with a significant reduction in the frequency and severity of side effects. It also offers greater convenience for patients and physicians.(2)
- VELCADE EPAR http://www.ema.europa.eu/ (accessed September 2012); VELCADE® revised SPC, approved 20.09.2012. The approved SPC is due to be published on the EC Community Register of medicinal products:http://ec.europa.eu/health/documents/community-register/html/newproc.htm#h and available upon request from Janssen.
- Moreau P, Pylypenko H, Grosicki S. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40