FDA approves Spectrum’s oncology drug Levoleucovorin

Levoleucovorin is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. The company currently expects the commercial launch of the product by June 2008.

Richard Bender, chief medical officer of Spectrum, said: “Levoleucovorin provides physicians and patients with an important treatment alternative to leucovorin. With this drug, patients undergoing cytotoxic chemotherapy are spared the administration of the pharmacologically inactive dextro-isomer. Preclinical studies have shown that the dextro-isomer may compete with the active levo-isomer for transport into cells.”