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Genta appeals "not approvable" decision for Genasense

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In response to a December 2006 "not approvable" letter for Genasense, Genta appeals the decision through the agency's formal dispute resolution process. The firm seeks approval of the Bcl-2 inhibitor for use in combination with fludarabine and cyclophosphamide to treat patients with relapsed or refractory chronic lymphocytic leukemia. Among the firm's arguments in the appeal are that the pivotal Phase III trial achieved its primary endpoint of complete response, which was doubled in the treatment arm compared to the control group (17 percent vs. 7 percent), and that complete response confers clinical benefit in CLL. Responses to CDER appeals are typically made within 30 to 60 days...
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