GENZYME'S PEDIATRIC LEUKEMIA DRUG APPROVED FOR MARKET

The FDA has granted marketing approval for Clolar, a drug manufactured by Genzyme that serves as a leukemia treatment for children with refractory or relapsed acute lymphoblastic leukemia (ALL).

Clolar (clofarabine) has received orphan drug designation for adult and pediatric ALL, and will now have seven years of market exclusivity in pediatric ALL patients, Genzyme said.

The FDA also recently granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act. Genzyme said it expects to make Clolar commercially available as soon as possible in January, given that it is the first new leukemia treatment approved specifically for children in more than a decade.