Levact bendamustine regulatory update

The U.K.'s NICE terminated an appraisal of Levact bendamustine to treat indolent non-Hodgkin's lymphoma (NHL) that is refractory to rituximab or rituximab-containing regimens because it did not receive an evidence submission from Mundipharma. According to NICE, Mundipharma told the agency that further research was ongoing, but that data would not be available in a time frame that would allow NICE to produce timely guidance. Without a NICE appraisal for the indication, the decision to recommend use of Levact will be made by individual NHS organizations on a local level.

In March, CHMP issued a positive opinion recommending approval of Levact to treat indolent NHL, chronic lymphocytic leukemia (CLL) and multiple myeloma (see BioCentury, March 29). Astellas granted rights for bendamustine 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. 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. CHMP is part of the European Medicines Agency (EMA). ...