Spectrum Pharmaceuticals (Spectrum) has received a Complete Response Letter from the FDA regarding its supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) for injection. It is intended for the treatment of patients with advanced metastatic colorectal cancer.
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, it is indicated to toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Reportedly, 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 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, claims the company.