VELCADE® (bortezomib) for Injection is an antineoplastic agent available for injection into a vein (intravenously or IV) or under the skin (subcutaneously). VELCADE must not be administered into the spinal fluid (intrathecally). It has been approved by the FDA for the treatment of myeloma. For information about VELCADE, call Millennium at 1-866-VELCADE or the IMF hotline at (800) 452-CURE (800-452-2873).
Study met primary efficacy endpoint of non-inferiority between subcutaneous and intravenous administration. Study results also indicated overall similar safety profile with differences in incidence of peripheral neuropathy.
The US Food and Drug Administration (FDA) has approved subcutaneous VELCADE for the treatment of multiple myeloma. This approval was based on a large, international clinical trial that studied VELCADE injected under the skin compared with VELCADE injected into a vein. The 222 patients in this study had been treated for their myeloma and relapsed.