(By Balaseshan) Astex Pharmaceuticals Inc. (NASDAQ:ASTX) said a committee of the European Union agency granted a positive opinion recommending approval of acute myeloid leukemia therapy.
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. Janssen is the licensee for Dacogen in territories outside of the United States, Canada and Mexico.
Dacogen (decitabine) for Injection is in treating adult patients 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.
The CHMP is the committee responsible for the scientific assessment of products seeking centralized marketing authorization throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen expect to receive the regulatory decision from the Commission in the end of the third quarter of 2012.
The CHMP positive opinion is based on data from the DACO-016 trial, the largest AML trial to date in this population of older patients. Key results from this study were published in the Journal of Clinical Oncology in June 2012.
This randomized, open-label, multi-center phase 3 clinical trial compared Dacogen versus patient's choice with physician's advice of either supportive care or low-dose cytarabine in patients 65 years and older with newly diagnosed de novo or secondary acute myeloid leukemia and poor- or intermediate-risk cytogenetics.
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.
Dacogen is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 30 countries worldwide including key markets such as the United States, Brazil, China, India, Korea, Russia and Turkey.
ASTX is trading up 13.06% at $2.51 on Friday. The stock has been trading between $1.51 and $3.16 for the past 52 weeks.