FDA Approves Levoleucovorin Injection for Multiple Indications

The Food and Drug Administration (FDA) approved levoleucovorin (Khapzory) for injection for 3 indications.

The agent, which is a chemotherapy protective drug, is approved for the following:

• Rescue after high-dose methotrexate therapy—a medicine used to treat cancer–in patients with osteosarcoma
• Diminishing the toxicity associated with over-dosage of folic acid antagonists—a type of drug that stops cells from using folic acid to make DNA and may kill cancer cells–or impaired methotrexate elimination
• The treatment of patients with metastatic colorectal cancer in combination with fluorouracil (Adrucil), a type of chemotherapy

For methotrexate toxicity, levoleucovorin is usually given every 6 hours for 10 doses. For colorectal cancer, the drug is usually given daily as a 5-day treatment, repeated every 4 to 5 weeks.

Common adverse events with levoleucovorin include nausea, vomiting, diarrhea, or mouth sores.

“Khapzory is the first levoleucovorin product approved by the FDA that contains sodium in its formulation,” Joe Turgeon, president and chief executive officer of Spectrum Pharmaceuticals, the agent’s manufacturer, said in a statement. “This (new drug application) submission was part of the lifecycle management of our legacy product, Fusilev.”