(Reuters) - An independent advisory panel to the U.S. health regulator said that Japanese drugmaker Eisai Co Ltd’s Dacogen did not show a favorable risk-benefit profile to treat a type of blood cancer.
The panel of independent experts voted 10-3 against the drug and expressed concerns about the survival benefits when treating acute myeloid leukemia. One panel member abstained from voting.
Dacogen, generically known as decitabine, is meant to treat the ailment in patients 65 years and older for whom chemotherapy has not worked.
The U.S. Food and Drug Administration usually follows the recommendations of its expert panels.
On February 7, FDA staff questioned the data on the drug and said a clinical trial for Dacogen did not meet the trial’s goal of improving overall survival.
Dacogen is already approved to treat myelodysplastic syndromes — a group of diseases in which the production of blood cells by the bone marrow is disrupted.
The drug was developed by SuperGen which later merged with UK-based biotechnology firm Astex Therapeutics Ltd to form Astex Pharmaceuticals.
Reporting by Esha Dey in Bangalore; Editing by Sreejiraj Eluvangal