Spectrum plunges on FDA letter delaying Fusilev approval in advanced metastatic colorectal cancer

California, USA-based Spectrum Pharmaceuticals says that it received a Complete Response letter from the Food and Drug Administration regarding its supplemental New Drug Application for Fusilev (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.

The news saw Spectrum's shares fall 14.7%, to $5.30 in premarket trading, and close on October 9 at $5.06, down 18.5%. The stock has ranged from 55 cents to $10 over the past year.

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 the agency to discuss options for continuing to seek approval of the drug in advanced metastatic colorectal cancer. Spectrum says it 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 is currently FDA approved and Marketed by Spectrum for:
o rescue after high-dose methotrexate therapy in osteosarcoma;
o to diminish the toxicity and counteract the effects of impaired methotrexate elimination; and,
o inadvertent overdosage of folic acid antagonists.