Pomalidomide (Pomalidomide Celgene®) has been granted a licence for use in myeloma patients across Europe. This decision by the European Commission follows the positive recommendation in May 2013 for pomalidomide by the Committee for Medicinal Products for Human Use (CHMP), within the European Medicines Agency (EMA).
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®.
Smouldering myeloma patients are generally not treated until symptoms develop. The current standard of care is observation. Previous attempts at treating smouldering myeloma with older treatments such as alkylating agents either were not effective or led to concerns about long-term toxicity.