Spectrum gets FDA nod for Khapzory
Spectrum Pharmaceuticals has received the Food and Drug Administration’s approval for Khapzory (levoleucovorin) for injection.
The product is a folate analog that is indicated 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 the 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,” Spectrum Pharmaceuticals president and CEO Joe Turgeon said in a statement. “This NDA submission was part of the lifecycle management of our legacy product, Fusilev. Our focus remains on the development of novel, targeted therapeutics including poziotinib and Rolontis.”
The product is a folate analog that is indicated 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 the 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,” Spectrum Pharmaceuticals president and CEO Joe Turgeon said in a statement. “This NDA submission was part of the lifecycle management of our legacy product, Fusilev. Our focus remains on the development of novel, targeted therapeutics including poziotinib and Rolontis.”