The Food and Drug Administration (FDA) has approved Khapzory (levoleucovorin; Spectrum Pharmaceuticals) for: rescue after high-dose methotrexate therapy in patients with osteosarcoma; diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination; and treatment of patients with metastatic colorectal cancer in combination with fluorouracil.
“Khapzory is the first levoleucovorin product approved by the FDA that contains sodium in its formulation,” said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. “This NDA submission was part of the lifecycle management of our legacy product, Fusilev.”
Khapzory, a folate analog, is expected to be available in January 2019. It will be supplied in single-dose vials containing 175mg and 300mg of levoleucovorin lyophilized powder for reconstitution before intravenous administration.
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