Genta Incorporated announced that the Company has submitted an amendment to the Food and Drug Administration (FDA) for its New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The submission is based on new information from the Company's completed Phase 3 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. The data were presented at an oral session at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Monday June 2, 2008.
Genta was notified in March 2008 that its appeal of a "non-approvable" decision for the Genasense NDA had been denied by FDA's Center for Drug Evaluation and Research (CDER). 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 FDA's decision. At this time, the Company cannot provide guidance regarding the expected duration of FDA review of this amendment.
"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," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer.
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