Leukaemia Therapy Dacogen Suffers Approval Setback

The FDA's Oncologic Drugs Advisory Committee said the supplemental New Drug Application did not support a favourable benefit-risk profile for acute myeloid leukaemia treatment.

Potential leukaemia drug Dacogen, co-developed by Eisai and Astex Pharmaceuticals, has suffered a setback after the FDA'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 syndro