The submission is based on new information from the company’s completed Phase III trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone.
Genta was notified in March 2008 that its appeal of a ‘non-approvable’ decision for the Genasense new drug application (NDA) had been denied by the FDA’s Center for Drug Evaluation and Research. However, that decision described a regulatory path forward that included but was not limited to determination of long-term survival in patients who entered the study. The company believes its submission comprises a ‘complete response’ to the FDA’s decision. At this time, the company cannot provide guidance regarding the expected duration of FDA review of this amendment.
Loretta Itri, chief medical officer of Genta, said: “We are pleased that the FDA will consider this new information, and we look forward to working with FDA staff during their review of this amendment to our NDA.”