Spectrum Pharmaceuticals (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Friday, October 29, 2010 it submitted a complete response to the "Complete Response" letter issued by 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.
“We believe that the additional data we submitted will satisfy the requirements of the FDA”
"We believe that the additional data we submitted will satisfy the requirements of the FDA," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We continue to expect a favorable regulatory decision."
The FDA requested additional data in support of the Company's sNDA filing for FUSILEV's use in advanced metastatic colorectal cancer, which has now been submitted. FDA has up to 60 days to formally accept the submission.
FUSILEV is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists.