ARTICLE | Clinical News

Treanda bendamustine regulatory update

April 18, 2011 7:00 AM UTC

The Scottish Medicines Consortium (SMC) recommended the use of Levact bendamustine on the National Health Service (NHS) in Scotland for first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate. However, the SMC recommended against the use of Levact as monotherapy in patients with indolent non-Hodgkin's lymphomas (NHL) who have progressed on rituximab or a rituximab-containing regimen and for first-line treatment of multiple myeloma (MM) in combination with prednisone in patients older than 65 years of age who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis.

Astellas granted rights to the alkylating agent to Cephalon in the U.S., to Mundipharma in Europe and to SymBio in Japan and certain Asian countries. SymBio then partnered the compound with Eisai in Japan, South Korea and Singapore, and with InnoPharmax in Taiwan. Cephalon markets bendamustine as Treanda in the U.S. to treat CLL and indolent B cell NHL. Mundipharma markets it as Ribomustin in Germany to treat CLL, NHL and MM. ...