Genasense in Chronic Lymphocytic Leukemia (CLL): During the quarter, Genta submitted an amendment to its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with relapsed/refractory CLL. The submission was based primarily 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. Subsequently, FDA has notified the Company that it considers Genta's submission as a complete response and a Class 2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal date for FDA's response of December 3, 2008. The submission requests marketing approval of Genasense for the proposed indication.
Tesetaxel: A Leading Oral Taxane with Anticancer Activity
In other regulatory activity, Genta submitted its response to a prior notice from FDA that had placed tesetaxel, a clinical-stage oral taxane, on full "clinical hold". During the quarter, the Company was notified by FDA that the clinical hold had been lifted and that Genta may resume clinical trials with tesetaxel.
Tesetaxel is the latest addition to the Genta oncology portfolio. The
agent was developed to avoid serious effects associated with other taxanes
(such as paclitaxel [Taxol(R); Bristol Myers Squibb] and docetaxel
[Taxotere(R); sanofi aventis]), including severe infusion reactions,
peripheral nerve damage, and drug resistance. More than 250 patients have
received tesetaxel, and the drug has demonstrated anticancer activity
|SOURCE Genta Incorporated|
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