|
On December 28, 2004, the U. S. Food and Drug Administration (FDA) granted marketing approval for clofarabine (Clolar) for treatment of pediatric patients with acute lymphoblastic leukemia. Genzyme Corp. won approval under an accelerated government approval process for products that may offer improvements over existing therapies for serious or life-threatening diseases. Such approvals require studies after a drug's approval to verify clinical benefits. The drug won approval to treat patients aged 1 to 21 who have exhausted other treatment options. The FDA granted Clolar orphan drug status, which provides seven years of market exclusivity for treating pediatric cases of the most common form of childhood leukemia. In mid-stage trials, Genzyme said 20 percent of patients treated with Clolar showed complete remission, while 10 percent of all patients achieved a partial response. Genzyme, which acquired rights to the drug through its acquisition of San Antonio-based Ilex Oncology Inc., said it expects to make Clolar commercially available "as quickly as possible in January 2005". The company said it also will study Clolar for use in treating adult leukemia and solid tumor cancers. |
