FDA has issued Spectrum Pharmaceuticals a complete response letter stating that the sNDA for Fusilev did not demonstrate that it was “noninferior” to leucovorin in treating advanced metastatic colorectal cancer. The company will request a meeting with the agency to discuss options for Fusilev in this indication.
Spectrum’s drug, a novel folate analog, is already sanctioned for use after high-dose methotrexate therapy in osteosarcoma. It is also approved to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. It is available in vials as freeze-dried powder. The firm’s sNDA covered Fusilev for injection as a treatment for patients with advanced metastatic colorectal cancer.
Leucovorin, a folic acid analog, is also approved to prevent harmful effects of methotrexate when used in certain cancers and to treat people who have accidentally received an overdose of methotrexate or similar medications.