Spectrum Pharmaceuticals Receives FDA Approval of KHAPZORY™ (levoleucovorin) for injection
Spectrum Pharmaceuticals, Inc.(NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications:
• Rescue after high-dose methotrexate therapy in patients with osteosarcoma.
• Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.
• The treatment of patients with metastatic colorectal cancer in combination with fluorouracil.
KHAPZORY 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.
“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. Our focus remains on the development of novel, targeted therapeutics including poziotinib and ROLONTIS.”
Spectrum is currently evaluating strategic options on the launch of KHAPZORY. Product supply will be available in January.
Important Safety Information for KHAPZORY
Contraindications
• KHAPZORY is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid, or folinic acid.
Warnings and Precautions
• Increased gastrointestinal toxicities with fluorouracil: Gastrointestinal toxicities, including stomatitis and diarrhea, occur more commonly and may be of greater severity and of prolonged duration. Deaths from severe enterocolitis, diarrhea, and dehydration have occurred in elderly patients receiving weekly d,l-leucovorin and fluorouracil. Do not initiate or continue therapy with KHAPZORY and fluorouracil in patients with symptoms of gastrointestinal toxicity until those symptoms have resolved. Monitor patients with diarrhea until it has resolved as rapid deterioration leading to death can occur.
• Drug interaction with trimethoprim-sulfamethoxazole: Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jiroveci pneumonia in patients with HIV infection increased treatment failure and morbidity.
Adverse Reactions
• The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue were stomatitis (38%) and vomiting (38%).
• The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer were stomatitis (72%), diarrhea (70%), and nausea (62%).
Drug Interactions
Leucovorin products increase the toxicity of fluorouracil.
Use in Specific Populations
Levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. Refer to methotrexate and fluorouracil prescribing information for additional information.
Please see full Prescribing Information for KHAPZORY available at KHAPZORY.com
