The new drug application (NDA) proposed the use of Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia. The recent submission was based on new information from the company’s completed, randomized Phase III trial that showed 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 the FDA’s Center for Drug Evaluation and Research that denied Genta’s appeal of a prior ‘non-approvable’ decision of the Genasense NDA in December 2006.
The FDA has informed the company that it considers Genta’s complete response as a Class 2 resubmission with a Prescription Drug User Fee Act goal date of December 3, 2008.