Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, announced that it received a Complete Response letter from the US Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.
The FDA stated in the Complete Response letter that the submission did not demonstrate that Fusilev is non-inferior to leucovorin; and recommended that the company meet with them to discuss options for continuing to seek approval of Fusilev in advanced metastatic colorectal cancer. The company plans to promptly request such meeting to discuss options for Fusilev in this indication.
The FDA did not request any changes to the currently approved indications and package insert.
Fusilev, a novel folate analog, is available in vials as freeze-dried powder. Fusilev rescue is also indicated after high-dose methotrexate therapy in osteosarcoma. Additionally, Fusilev is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosage of folic acid antagonists. Fusilev has been marketed outside the United States by Wyeth, sanofi-aventis, Takeda, and others for more than 10 years.