Astex Pharmaceuticals (ASTX) Release: DACOGEN® Receives a Positive Regulatory Recommendation in the European Union for Treatment of Acute Myeloid Leukemia
7/20/2012 9:14:22 AM
DUBLIN, Calif., July 20, 2012 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that Janssen-Cilag International NV was notified that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion recommending approval of DACOGEN® (decitabine) for Injection in the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification who are not candidates for standard induction chemotherapy. Janssen is the licensee for DACOGEN in territories outside of the United States, Canada and Mexico.
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