The European Commission granted a licence for the use of two new indications of Velcade® (bortezomib) in the treatment of myeloma. It has approved its use as an induction treatment for newly diagnosed patients prior to high-dose therapy and autologous stem cell transplantation and as a retreatment in relapsed myeloma patients (in combination with thalidomide and dexamethasone) who have previously responded well to Velcade®.
This decision by the European Commission follows the positive recommendation in July 2013 for Velcade in these two new settings by the Committee for Medicinal Products for Human Use (CHMP), within the European Medicines Agency (EMA).
MPE Vice-Chair, Eric Low said that “the approval of Velcade® as part of induction treatment in myeloma is very good news. Patients deserve access to optimal treatment combinations in this setting. Achieving the best possible response in this setting correlates with better survival outcomes and improved quality of life for patients. In addition, being able to use Velcade® again in patients who had responded well to initial treatment with Velcade® is a huge step forward.”
You can see the full press release of 8 August 2013 here.