"Fusilev has been approved and used to treat colorectal cancer for over a decade in Europe and Japan. Outside the US, Fusilev is marketed by Wyeth (NYSE: WYE) and Takeda (PINK:TKPHY) and brings in approximately $200 million in annual revenue.
Colorectal Cancer: A generic version of leucovorin is widely used in the US and typically prescribed in doses of 500 mg. Leucovorin or is most often used in conjunction with 5-FU a common treatment for colorectal cancer.
While the generic version currently prescribed to patients in the US is an inactive isomer, Fusilev is a pure active isomer of leucovorin.
Pure Isomer (Fusilev) v. Inactive Isomer (generic leucovorin): The inactive isomer tends to compete with the active isomer and leads to more variability of biological outcome. This means, patients tend to react to the inactive isomer version (generic leucovorin) with more variability. Such variability is not as noticeable in the pure isomer version (Fusilev).
Head to Head Study: A study comparing equivalent doses of Fusilev and generic leucovorin indicated there was a statistically significant reduction in toxicity with Fusilev. The results showed there was nearly a complete reduction in severe grade 3 and 4 toxicities in patients treated with Fusilev. It is worth pointing out that Fusilev is prescribed in 250 mg doses, half that of generic leucovorin.
Due to the benefits of less variability and reduced toxicity, Fusilev should be preferred over the existing generic version with more variability and increased toxicity."
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