Treanda bendamustine regulatory update

Cephalon disclosed in an SEC filing that FDA approved the company's sNDA to update the label for Treanda bendamustine to include 2 post-marketing cases of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) when used in combination with allopurinol. The company noted that allopurinol is known to cause serious skin reactions. In the filing, the company said 1 of the cases was fatal. The updated prescribing information will be finalized and implemented in early May. Treanda is marketed in the U.S. to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin's lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. Astellas granted rights for bendamustine to Cephalon in the U.S., to Mundipharma in Europe and to SymBio in Japan and certain Asian countries. Treanda is an alkylating agent. ...