Spectrum Pharmaceuticals, Inc. has filed a supplemental new drug application (NDA) with the U.S. Food and Drug Administration for an expanded indication for its agent Fusilev™ (levoleucovorin).
Fusilev is already approved for use following high-dose methotrexate among patients with osteosarcoma and to reduce toxicities and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. Fusilev is comprised of the pharmacologically active enantiomer of leucovorin. Levoleucovorin is currently listed as a replacement for calcium leucovorin in the NCCN Guidelines.
The supplemental NDA is for the use of patients who suffer from vitamin deficiency following chemotherapy for the treatment of colorectal cancer. Spectrum Pharmaceuticals expects a response in the third or fourth quarter of 2009.
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