Levact Recommended in EU to Treat Blood Cancers

21 March 2010 (Last Updated March 21st, 2010 18:30)

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 authori

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.