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news.Cephalon has reported that it is to file a new drug application with the FDA for its leukemia drug Treanda.
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The company will file the application in the third quarter of 2007 for the drug, which is for the treatment of chronic lymphocytic leukemia (CLL).
“Treanda offers a new and alternative treatment approach to cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia,” said Dr Lesley Russell, executive vice president, worldwide medical and regulatory operations.
A multi-center phase III clinical trial conducted in Europe evaluated the safety and efficacy of bendamustine, the active ingredient in the drug, compared to chlorambucil in patients with treatment-naive B-CLL.
The data from this trial met its primary endpoint of overall response rate and will be the basis for the company’s NDA filing for the CLL indication. The company anticipates that results from this study will be released at the upcoming American Society of Hematology annual meeting in December 2007.
Cephalon’s phase III clinical trial evaluating the safety and efficacy of Treanada in patients with indolent non-Hodgkin’s lymphoma (NHL) who are refractory to the monoclonal antibody rituximab remains on schedule. The company anticipates filing an NDA for this indication in the fourth quarter of 2007.