Knobias Clip Report (07-12-2008) GNTA
Submitted By Knobias ClipReport
GNTA: FDA Accepts NDA Amendment for Genasense(R) as “Complete Response”
By Fain Hughes, fhughes@knobias.com
Genta Incorporated (GNTA) announced that the 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.
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