R&D In Brief: Oncology
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genta submits five-year Genasense survival data: An NDA amendment based on increased five-year survival data for relapsed or refractory chronic lymphocytic leukemia patients who responded to Genasense (oblimersen) is submitted as a complete response to FDA's December 2006 "not approvable" letter for the Bcl-2 inhibitor, Genta announces June 6, after presenting the data to ASCO on June 2. Genta had appealed the "not approvable" action, but in March was notified that its appeal had been denied. The denial, however, described a pathway forward that included, but was not limited to, showing increased long-term survival. Genta's response contains new information from a completed Phase III trial showing a significant increase in overall survival for patients with relapsed or refractory CLL who received Genasense plus chemotherapy compared with patients who received chemotherapy alone. Genta said it could not provide guidance on the likely duration of FDA's review of the NDA amendment; a typical six-month review of a major amendment would place the user fee goal date at Dec. 6 or earlier
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