Biotechnology company Spectrum Pharmaceuticals has announced that in order to meet the needs of cancer patients in the United States, the company has substantially increased its manufacturing capacity of Fusilev (levoleucovorin) for injection, since its approval for use in advanced metastatic colorectal cancer.
Spectrum has qualified and maintains multiple third-party manufacturing facilities approved by the US Food & Drug Administration (FDA) for the company's oncology drug, Fusilev, which was approved in 2011 for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
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.
"Spectrum's mission — to serve the needs of the cancer community — is exemplified by our commitment to those with colorectal cancer, a terrible disease inflicting approximately 400 new patients every day in the US," said Rajesh C Shrotriya, MD, chairman, chief executive officer, and president of Spectrum Pharmaceuticals. "It is our goal to provide sufficient quantities of Fusilev so no patient goes untreated. To this end, Spectrum embarked on a manufacturing plan to expand capacity that can supply the demand of the entire patient population. Access to multiple manufacturing facilities approved by the FDA greatly reduces the risk of supply interruptions, giving physicians and patients the strong reassurance of availability they need. Spectrum provides Fusilev free of charge through its Spectrum Therapy Access Resources (STAR) programme to eligible patients who cannot otherwise afford their medication."
"We have taken steps to expand our manufacturing capabilities as we are currently experiencing increasing demand for Fusilev, which we anticipate to continue throughout 2012 and beyond," concluded Dr Shrotriya.
According to the American Cancer Society, colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the US, with approximately 141,210 new cases and 49,380 deaths reported in 2011.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, Fusilev and Zevalin.