FDA accepts Genta's complete response on Genasense

The Food and Drug Administration has accepted US firm Genta's amendment to its New Drug Application for Genasense (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. The recent submission was based on new information from the company's completed, randomized 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.

The amendment responds to a communication received in March from the FDA's Center for Drug Evaluation and Research that denied Genta's appeal of a prior "non-approvable" decision of the 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. The FDA has informed Genta that it considers its complete response as a Class 2 resubmission with a Prescription Drug User Fee Act goal date of December 3 this year.