FDA grants clofarabine additional exclusivity

The FDA will grant six months of extended market exclusivity to ILEX Oncology's clofarabine under the Best Pharmaceuticals for Children Act.

Clofarabine is currently under priority review by the FDA for the treatment of refractory or relapsed acute leukaemia in children. If approved by the FDA, clofarabine would be the first drug to be labelled initially for pediatric leukaemia in more than a decade.

'This is an important milestone for children with cancer and for the FDA because children are usually an afterthought in oncology drug development,' said Children's Cause for Advocacy President, Dr Susan Weiner. 'Hopefully this good news will set a precedent for other companies to make children with cancer a priority in their drug development plans.'

The Best Pharmaceuticals for Children Act offers extended market exclusivity to drug developers as an incentive to increase therapeutic research in children.

Clofarabine was previously granted orphan drug designation for the treatment of adult and pediatric acute lymphoblastic leukaemia and acute myeloid leukaemia. In the United States, orphan drug status provides for seven years of market exclusivity for the orphan drug indication following the FDA's marketing approval.

About Clofarabine

Clofarabine is a next generation of the drug class purine nucleoside analogues which all inhibit DNA production necessary for cancer cell growth