"The approval of VELCADE today brings renewed hope to thousands of European multiple myeloma patients and their families" said Eric Low, Executive Director, International Myeloma Foundation (UK). "The multiple myeloma advocacy community has campaigned tirelessly over the years for cutting edge treatments such as VELCADE to be made available to patients, this is a very proud day", he continued.
The findings of a pre-specified interim analysis from an ongoing phase III trial which compared VELCADE to dexamethasone in refractory multiple myeloma patients found a statistically significant improvement in time to disease progression the primary endpoint of the trial in patients receiving VELCADE compared to patients receiving high-dose dexamethasone. Patients in the control arm of the trial were given the opportunity to switch to VELCADE as soon as possible based on an interim analysis that found a statistically significant improvement in TTP in patients receiving VELCADE compared to patients receiving dexamethasone.
VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. There are approximately 50 ongoing clinical trials (in Europe and the US) investigating the potential of VELCADE in all stages of multiple myeloma and other cancers.
A single licence has been granted to market VELCADE in the 15 member states of the EU, plus Norway and Iceland. In addition it will be available in the 10 accession countries.