Spectrum introduces Fusilev for injection

Fusilev, a novel folate analog, is available in 50mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. Fusilev rescue is indicated after high-dose methotrexate therapy in osteosarcoma.

The company has recently filed an amendment to its pending new drug application (NDA) for Fusilev tablets. The company continues to work on the supplemental NDA for use of the parenteral formulation in combination with 5-FU containing regimens in advanced metastatic colorectal cancer.

As a result of pre-NDA consultation, the FDA has recommended a more comprehensive scope of data analysis as the basis for registration in this indication. The company anticipates filing the supplemental NDA for colorectal cancer by the end of October 2008.

Rajesh Shrotriya, chairman, CEO and president of Spectrum, said: “The launch of Fusilev establishes the foundation of Spectrum’s commercial oncology franchise. We believe the market potential of Fusilev, as a replacement for leucovorin, could be significant.”