Astex Pharmaceuticals, Inc. (ASTX) Thursday said the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee voted 10 to 3 against a favorable benefit-risk profile for Dacogen. The drug is indicated in the treatment of acute myeloid leukemia in adults 65 years of age or older who are not considered candidates for induction therapy.
Astex shares plunged over eight percent following the news. FDA has the option of seeking the advice of its advisory committees when reviewing a new drug application, although it is not obliged to follow the committee's recommendation. The PDUFA date is March 6, 2012.
The advisory committee reviewed data from Astex's partner Eisai whose supplemental New Drug Application or sNDA was accepted for FDA review in July 2011. The application is based on the open-label Phase III clinical trial (DACO-016) data.
DACO-016 trial was undertaken in 485 patients and compared Dacogen (decitabine) to a patient's treatment choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with acute myeloid leukemia. The primary endpoint of the study was overall survival.
The analysis demonstrated an increase of greater than 50 percent in median overall survival in patients taking decitabine, 7.7 months for decitabine patients compared to 5.0 months for patients in the comparator arm.
Astex developed Dacogen for Injection is approved in the United States for treatment of patients with myelodysplastic syndromes or MDS. Dacogen is currently approved for the treatment of MDS in about 30 countries. Dacogen is licensed to Eisai Co., Ltd and Eisai has licensed rights outside of North America to Janssen-Cilag International NV and other affiliates of Cilag GmbH International. Astex receives royalties on global sales of Dacogen.
In 2004, Astex granted Eisai exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen.
Astex has four products in or entering Phase II trials which are expected to produce clinical proof of concept data in the next 12 to 18 months.
In after-hours, ASTX is trading at $2.00, down $0.19 or 8.68%, on the Nasdaq. Over the past year, the stock traded in a range of $1.51 - $3.35.
by RTT Staff Writer
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