FDA News

FDA Accepts Genta's NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia

(July 15, 2008)-- Genta has announced that the Food and Drug Administration (FDA) has accepted the Company's amendment to its New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection as a "complete response". The NDA proposed the use of Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The recent submission was based on new information from the Company's completed, randomized 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 amendment responds to a communication received in March 2008 from FDA's Center for Drug Evaluation and Research (CDER) that denied Genta's appeal of a prior "non-approvable" decision of the Genasense NDA in December 2006. That communication described a regulatory path forward that included but was not limited to determination of long-term survival in patients who entered the study. FDA has informed the Company that it considers Genta's complete response as a Class 2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal date of December 3, 2008.

"We are pleased that the FDA will formally review this new information, and we look forward to working with FDA's Division of Oncology Drug Products during their consideration of this amendment," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer.

For more information about Genta, please visit www.genta.com.

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