(By Balaseshan) Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) said it expanded manufacturing capacity to ensure long-term supply of Fusilev to treat advanced metastatic colorectal cancer. Following the news, shares rose 1.95% in premarket.
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.
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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 (NYSE: PFE), Sanofi-Aventis (NYSE: SNY), and Takeda.
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According to the National Cancer Institute, Colorectal Cancer is the third most commonly diagnosed cancer in the U.S. There were about 141,210 new cases of Colorectal Cancer diagnosed in 2011, almost 400 per day. 1.11 million people are currently living with colorectal cancer in the U.S., and 49,380 deaths were estimated in 2011, almost 136 per day.
SPPI closed Monday's regular session at $11.28. The stock has been trading between $9.31 and $17.48 for the past 52 weeks.