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news.The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals' treatment for advanced metastatic colorectal cancer, Fusilev (levoleucovorin) for use in conjunction with 5-fluorouracil.
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Fusilev is a folate analog, which is approved as a ready-to-use (Fusilev injection) solution in 175mg and 250mg vials, and as freeze-dried powder (Fusilev for injection) in 50mg vials.
Fusilev is being marketed under various trade names by Wyeth, Sanofi-Aventis and Takeda, outside the US.
Spectrum Pharma president, chairman and CEO Rajesh Shrotriya said although the NCCN Guidelines in the US already recommend levoleucovorin in the treatment of colorectal cancer patients, they could not promote Fusilev for this indication until now.
"Fusilev, under various trade names, has been available in Europe and Japan primarily by Wyeth, Sanofi-Aventis and Takeda Pharmaceuticals," Shrotriya said.