Levact(R) (bendamustine) Recommended for Approval in Europe for Treating Blood Cancers

Saturday, March 20, 2010 Cancer News J E 4
CAMBRIDGE, England, March 19, 2010 Mundipharma announcedtoday that the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) has issued a positive opinion recommendingthat marketing authorisations can be granted in Germany and the followingMember States of the EU: Austria, Belgium, Denmark, Finland, France, Ireland,Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom (UK) for theuse of bendamustine in the treatment of patients with indolent non-Hodgkin'slymphoma (NHL), chronic lymphocytic leukaemia (CLL) and multiple myeloma(MM).[1] If adopted by EU authorities, bendamustine will be another vitaltreatment in the fight against blood cancers.

Dr Thomas Mehrling from Mundipharma commented, "We are delighted withthis decision and believe it represents a dramatic step towards improvedtreatment for patients with haematological malignancies."

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

Bendamustine is a highly effective chemotherapy agent which differs fromthose that are already available due to its unique chemical structure andactivity.[2] The announcement is particularly important for those patientswith common white blood cell malignancies, notably indolent NHL, CLL and MM,including those patients with indolent NHL that have not responded to othertherapies, or those patients where their cancer has returned after a periodof absence.

Bendamustine is currently licensed in Germany (under the brand nameRibomustin(R)) for CLL, first-line therapy of advanced indolent NHL in acombination protocol, and in combination with prednisone for advanced MMstage II with progress or stage III.[3] Between 2008 and 2009, bendamustinewas used to treat 13,357 patients in Germany.[4] In the United States,bendamustine is indicated for the treatment of indolent B-cell NHL that hasprogressed during or within six months of treatment with rituximab or arituximab-containing regimen and also for the treatment of patients withCLL.[5] Since its launch, 14,000 patients have been treated in the UnitedStates.[6]

"New treatments capable of inducing further remission without excessivetoxicity are urgently needed. Many of the patients who may benefit frombendamustine currently have no or few treatment options available. Thisproduct provides these patients with renewed hope" commented Professor MarcoMontillo, Department of Haematology, Niguarda Ca'Granda Hospital, Milan,Italy.



[1] European Medicines Agency website: Accessed March 2010:

[2] Leoni LM et al, Bendamustine (Treanda) Displays a Distinct Pattern ofCytotoxicity and Unique Mechanistic Features Compared with Other AlkylatingAgents. Clin Cancer Res 2008; 14(1):309-317[3] Ribomustin SPC [4] IMS Oncology Analyzer- data on file [5] Treanda website: Accessed March 2010: [6] Tandem Audit 2010-data on file

SOURCE Mundipharma


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