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DUBLIN, Calif., Sept. 28, 2012 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for DACOGEN® (decitabine) for 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.
[i] DACOGEN also has been granted Orphan Drug designation for the treatment of AML.
The data in support of the marketing authorization is based on the Phase 3 DACO-016 trial that compared decitabine to patients' choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML. The analysis of the protocol-specified results demonstrated an increase of 54 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; HR=0.85, 95 percent CI: 0.69 to 1.04, p=0.108). An updated analysis of mature survival data confirmed this strong trend for improved overall survival and provided clinically significant evidence of the efficacy of decitabine (HR=0.82; 95 percent CI: 0.68 to 0.99; nominal p=0.037).
"We are pleased that elderly AML patients who are not candidates for standard induction chemotherapy in the European Union can now be offered treatment with DACOGEN, the world's first medicine approved and labelled specifically for elderly AML," said James S.J. Manuso, PhD, chairman and chief executive officer of Astex Pharmaceuticals.
DACO-016, with 485 study subjects, is the largest AML trial to date in older patients. It was a Phase 3, randomized, open-label trial, in newly diagnosed patients ≥65 years of age with de novo or secondary AML and poor- or intermediate-risk cytogenetics. Patients were enrolled globally at 65 clinical sites. Of the 485 patients, 242 were randomized to decitabine and 243 to patient's treatment choice of supportive care or low-dose cytarabine (majority of patients, 88%). Patients treated with decitabine received a 1-hour infusion, once daily for 5 consecutive days every 4 weeks. Patients treated with cytarabine received 20 mg/m2 subcutaneously once daily 10 consecutive days every 4 weeks. The median duration of treatment for patients on the decitabine arm was 4.4 months, compared with 2.4 months in the cytarabine group.
Adverse events (AEs) were consistent with the known decitabine safety profile and no major differences between the treatment arms were observed. The most frequently reported Grade 3 or 4 hematologic AEs were thrombocytopenia, anemia, neutropenia, and febrile neutropenia.
[ii]About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is an aggressive, fast-growing cancer that starts inside the bone marrow with production of abnormal blood cells. It is generally a disease of older adults, with an average patient age of 64 at diagnosis, and is slightly more common among men than women. The most common symptoms of AML include tiredness, shortness of breath, bruising or bleeding easily, fever and infections. AML can sometimes spread to other parts of the body including the lymph nodes, liver and spleen. When diagnosed, treatment is to be started with minimal delay as AML usually results in death within just a few months if left untreated.
[iii] In older adults, induction chemotherapy leads to a high 30-day mortality, and most patients are not candidates for or are unwilling to undergo this intensive therapy. Therefore, treatment options are limited and overall, irrespective of therapy, median survival is merely 2.4 months.
[iv]About DACOGEN® (decitabine)
DACOGEN is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 35 countries worldwide including key markets such as the United States, Brazil, China, India, Korea, Russia and Turkey.