Astex receives regulatory recommendation for Dacogen
24 July 2012 16:48 in Scientific Company News
Astex has welcomed news that the innovative cancer drug Dacogen has been recommended for European approval by the Committee for Medical Products for Human Use (CHMP).
The European Medicines Agency committee has granted a positive opinion endorsing Dacogen as an injection-based treatment for elderly patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy.
Dacogen is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes in more than 30 countries, with Janssen-Cilag holding its marketing and development rights in most territories worldwide.
This CHMP recommendation is based on positive data from DACO-016, the largest AML trial to date among patients aged over 65.
Dr James Manuso, chairman and chief executive officer of Astex Pharmaceuticals, said: "We look forward to the EMA's decision later this year with the hope that clinicians and patients in Europe may soon have access to this treatment option."
Earlier this month, the company celebrated the news that board member Dr Peter Fellner has earned the 2012 European Mediscience Award for most significant contribution to the mediscience sector.
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