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Oct 29, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Bendamustine regulatory update

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...

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