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Home » GENTA INITIATES NEW DRUG APPLICATION FOR GENASENSE
GENTA INITIATES NEW DRUG APPLICATION FOR GENASENSE
July 1, 2005
Genta announced that the company has initiated submission of a new drug application (NDA) with the FDA seeking marketing approval of Genasense Injection, its lead anticancer compound.
The NDA seeks accelerated approval for the use of Genasense (oblimersen sodium) in combination with fludarabine plus cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia (CLL) who have previously received fludarabine. Genasense has received fast-track designation by FDA in CLL, meaning that the indication represents an unmet medical need. Fast-track designation enables the company to submit the NDA on a "rolling" basis as specific sections are completed. Genta has submitted the initial section, and the company anticipates that the NDA will be completed within six months.
Genasense has also received designation as an orphan drug in CLL, which provides for a period of marketing exclusivity, certain tax benefits, and exemption from certain fees at the time of NDA submission. Accelerated approval will require the company to conduct a confirmatory study, and Genta plans to discuss the design of that study with FDA.
The NDA in CLL includes a Phase I-II study of Genasense alone in patients with relapsed or refractory CLL, and a randomized Phase III clinical trial of fludarabine plus cyclophosphamide with or without Genasense in 241 patients with advanced CLL who had previously received treatment with fludarabine. The CLL data will be supported by safety data obtained in more than 1,000 patients who received Genasense in clinical trials in other indications. The primary endpoint of the Phase III trial was to compare the proportion of patients who achieved a complete response or a nodular partial response. Results of the Phase III trial, which were updated in May 2005 at the annual meeting of the American Society of Clinical Oncology.
KEYWORDS Drug Pipeline Alert
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