Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the U.S. Food & Drug Administration (FDA) has approved an additional manufacturing facility for the production of FUSILEV® (levoleucovorin) for injection. Spectrum has continued to increase the number of qualified third-party manufacturing sites approved for FUSILEV production since this product was approved in 2011 for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
"During 2012, we have undertaken significant expansion efforts to grow our infrastructure and capabilities, enlarge and realign our sales force, and further tailor our promotional and other initiatives to meet our customers’ needs. All of these programs will be critical as we continue to significantly increase our hematology and oncology footprint,” said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Adding a manufacturing site further differentiates us from single-source suppliers, which can pose supply chain risks. Multiple production sites help ensure long-term uninterrupted supply of FUSILEV, with our new facility allowing us to increase geographic diversification of supply.”
About Colorectal Cancer
According to the National Cancer Institute, Colorectal Cancer is the third most commonly diagnosed cancer in the US. There were about 141,210 new cases of Colorectal Cancer diagnosed in 2011, almost 400 per day. 1,110,000 people are currently living with colorectal cancer in the US, and 49,380 deaths were estimated in 2011, almost 136 per day. 11SEER Cancer Statistics Review, 1975-2008, National Cancer Institute. Bethesda, MD About FUSILEV® (levoleucovorin) for injection FUSILEV, a novel folate analog, is approved as a ready-to-use solution (FUSILEV Injection), and as freeze-dried powder (FUSILEV for Injection). FUSILEV is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. FUSILEV is also indicated 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. FUSILEV, under various trade names, is marketed outside the United States by Pfizer, Sanofi-Aventis, and Takeda.