sNDA review of Fusilev for treatment of metastatic colon cancer

Spectrum Pharmaceuticals announced that it has met with the FDA regarding its supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) injection for the treatment of advanced metastatic colorectal cancer. To complete its review, the FDA is requesting additional data, which Spectrum expects to submit in the third quarter of 2010, but is not requiring additional efficacy studies.

Fusilev is the pharmacologically active isomer of leucovorin and is available as a freeze-dried powder for IV injection after reconstitution.

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