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news.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion to Mundipharma recommending that marketing authorisations can be granted in Germany and the certain Member States of the EU for the use of Bendamustine in the treatment of patients with indolent non-Hodgkin's lymphoma (NHL).
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The EU states are Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the UK.
Mundipharma claimed that Bendamustine is a highly effective chemotherapy agent which differs from those that are already available due to its unique chemical structure and activity. The announcement is particularly important for those patients with common white blood cell malignancies, notably indolent NHL, CLL and MM, including those patients with indolent NHL that have not responded to other therapies, or those patients where their cancer has returned after a period of absence.
Bendamustine is currently 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.
The company said that 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. If adopted by EU authorities, bendamustine will be another vital treatment in the fight against blood cancers.
Marco Montillo, professor of department of haematology at Niguarda Ca’Granda Hospital in Milan, said: “New treatments capable of inducing further remission without excessive toxicity are urgently needed. Many of the patients who may benefit from bendamustine currently have no or few treatment options available.”