Potential leukaemia drug Dacogen, co-developed by Eisai and Astex Pharmaceuticals, has suffered a setback after the US Food and Drug Administration’s Oncologic Drugs Advisory Committee recommended against its approval.
The committee voted ten to three against, with one abstention, stating that the supplemental New Drug Application did not support a favourable benefit-risk profile for acute myeloid leukaemia treatment.
The application had been based on Phase III data compiled from 500 patients that demonstrated that the drug boosted life expectancy by an average of 7.7 months, more than the five months seen in patients who received best supportive care in the study.
Although Dacogen is already approved in the US for the treatment of patients with myelodysplastic syndromes, the committee ruled that the study failed to demonstrate benefit on statistical interpretation.
The drug did reach its secondary endpoint of progression-free survival; however the FDA ruled that the drug’s failure to meet its primary goal should be given preference when considering the drug’s efficacy.
Eisai and Astex have been seeking its approval for the treatment of adults aged 65 or older who are not considered viable candidates for induction therapy.
The FDA is due to announce its final decision by 6 March 2012.