The European Medicines Agency (EMA) has recommended marketing authorisation be granted for Mundipharma‘s Levact(bendamustine), to treat patients with indolent non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM).

The committee recommends that authorisation be given in Germany and the following member states of the EU: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the UK.

Following a European Commission decision on this positive opinion and the granting of national licences, the first launches of bendamustine in the EU are anticipated in mid-2010 in Austria, Denmark, Finland and the UK.

Bendamustine is a highly effective chemotherapy agent licensed in Germany (under the brand name Ribomustin) for CLL, first-line therapy of advanced indolent NHL in a combination protocol, and in combination with prednisone for advanced MM stage II with progress or stage III.