FDA Approves Khapzory Injection

The Food and Drug Administration (FDA) approved Khapzory (levoleucovorin) for injection for three 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 Adrucil (fluorouracil), a type of chemotherapy

“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 (levoleucovorin).”

For methotrexate toxicity, Khapzory is usually given every six hours for 10 doses. For colorectal cancer, the drug is usually given daily as a five-day treatment, repeated every four to five weeks.

Common side effects with Khapzory include nausea, vomiting, diarrhea or mouth sores.