Astex leukemia drug nets European recommendation

An advisory committee to Europe’s drug regulator recommended Friday that the agency approve a drug licensed out of Dublin-based Astex Pharmaceuticals Inc. for patients with acute myeloid leukemia.

The European Medicines Agency’s Committee for Medical Products for Human Use recommended that Dacogen injections be approved for people 65 or older with newly diagnosed or secondary AML who are not eligible for standard chemotherapy.

FDA rejects plan to expand use of Astex blood cancer drug

The Food and Drug Administration Tuesday rejected an attempt to expand the use of the blood cancer drug Dacogen, developed by Dublin’s Astex Pharmaceuticals Inc.
An FDA advisory panel last month recommended that the agency not approve the application by Eisai Co., which markets the drug in the United States.

FDA panel votes against Astex leukemia drug

An advisory panel did not recommend Thursday that the Food and Drug Administration approve a leukemia-fighting drug from Astex Pharmaceuticals Inc. and partner Eisai Co. Ltd.
The FDA’s oncology advisory committee voted 10-3 against recommending that Dacogen be approved for elderly patients with acute myeloid leukemia. One member abstained.
The recommendation is not binding, but the FDA typically follows a panel’s decision.
The FDA is scheduled to make its final decision March 6.