Published on October 13, 2009 at 1:34 AM
Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it received a Complete Response letter from the U.S. 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.
Source: Spectrum Pharmaceuticals, Inc.