Spectrum Pharmaceuticals announced that it received notification that the FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. Fusilev is the pharmacologically active isomer of leucovorin and is available as a freeze-dried powder for IV injection after reconstitution.  

Fusilev is already indicated for use in osteosarcoma, to reduce toxicity of high-dose methotrexate (MTX) therapy and to reduce toxicity and counteract effects of impaired MTX elimination and of inadvertent overdose of folic acid antagonists.

For more information call (877) 387-4538 or visit www.fusilev.com.