FDA approves Bendeka for CLL, NHL

FDA approved Bendeka bendamustine RTD ( EP-3102) from Teva Pharmaceutical Industries Inc. (NYSE:TEVA) and Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) to treat chronic lymphocytic leukemia and indolent B cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab.

Eagle CEO Scott Tarriff told BioCentury that Teva plans to use Bendeka as a line extension for Treanda bendamustine, which is reconstituted into a 500 mL bag and requires 30-60 minutes for an infusion. He said Bendeka -- a ready-to-dilute formulation of bendamustine, an alkylating agent, that can be reconstituted into a bag containing 50 mL saline or a mixture of sodium chloride and dextrose -- can be infused in 10 minutes and includes less sodium chloride. It has Orphan Drug status for CLL and indolent B cell NHL. ...