FDA News

FDA approves Khapzory for injection

The FDA approved levoleucovorin, a folate analog, for injection for three indications.

Levoleucovorin (Khapzory, Spectrum), which can prevent the harmful effects of chemotherapy, 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,” Joe Turgeon, president and CEO of Spectrum Pharmaceuticals, said in a company-issued press release. “This [new drug application] submission was part of the lifecycle management of our legacy product, Fusilev. Our focus remains on the development of novel, targeted therapeutics, including poziotinib [Spectrum] and Rolontis [eflapegrastim, Spectrum].”

Levoleucovorin is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.

The most common adverse reactions in patients receiving high-dose methotrexate therapy with levoleucovorin rescue included stomatitis (38%) and vomiting (38%). The most common adverse reactions in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer included stomatitis (72%), diarrhea (70%), and nausea (62%).

Levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid.

Spectrum is “evaluating strategic options” for the launch of the drug, which will be available in January, according to the press release.

The FDA approved levoleucovorin, a folate analog, for injection for three indications.

Levoleucovorin (Khapzory, Spectrum), which can prevent the harmful effects of chemotherapy, 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,” Joe Turgeon, president and CEO of Spectrum Pharmaceuticals, said in a company-issued press release. “This [new drug application] submission was part of the lifecycle management of our legacy product, Fusilev. Our focus remains on the development of novel, targeted therapeutics, including poziotinib [Spectrum] and Rolontis [eflapegrastim, Spectrum].”

Levoleucovorin is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.

The most common adverse reactions in patients receiving high-dose methotrexate therapy with levoleucovorin rescue included stomatitis (38%) and vomiting (38%). The most common adverse reactions in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer included stomatitis (72%), diarrhea (70%), and nausea (62%).

Levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid.

Spectrum is “evaluating strategic options” for the launch of the drug, which will be available in January, according to the press release.