BioCentury
ARTICLE | Clinical News

Bendamustine regulatory update

October 29, 2012 7:00 AM UTC

Teva said FDA issued a complete response letter for an sNDA for Treanda bendamustine for first-line treatment of indolent B cell non-Hodgkin's lymphoma (NHL) in combination with rituximab. The agency asked for additional progression-free survival (PFS) data from Phase III Study 3064 trial. Teva said it is evaluating its options and is requesting a meeting with FDA. The drug is approved in the U.S. to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin's lymphoma (NHL) in patients refractory to rituximab. ...