The company has also requested priority review of its application and, if granted, Clolar could be approved for this indication in the first half of 2009.
Genzyme’s supplemental new drug application (sNDA) seeks approval for Clolar’s use as a single agent in previously untreated adults aged 60 years or older with acute myeloid leukemia (AML) who have at least one unfavorable prognostic factor.
Genzyme will use the results of the Classic II study to support its label expansion filing. This large Phase II clinical trial demonstrated that patients with at least one pre-specified unfavorable prognostic factor who received single agent Clolar achieved a 45% overall remission rate, including a 40% complete remission rate and a 5% complete remission rate with incomplete platelet recovery.
Beth Trehu, vice president and general manager for clofarabine at Genzyme, said: “Clolar has an important role in the treatment of pediatric leukemia and has great potential to help a broader set of patients with hematological disorders. We are committed to fulfilling the potential of this product by expanding its indications and securing approvals globally.”