Erwinaze is specified as an element of a multi-agent chemotherapeutic regimen to treat patients suffering from acute lymphoblasticleukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
Jazz Pharmaceuticals executive vice-president research and development and chief medical officer Jeffrey Tobias said: "Administration of Erwinaze through an intravenous infusion provides physicians another option for patients including those who cannot tolerate intramuscular injections.
"Gaining FDA approval of this expanded label for Erwinaze reflects our continued commitment to improving patients’ lives."
As part of the approval process, based on the pharmacokinetic study of intravenous asparaginase Erwinia chrysanthemi afterhypersensitivity to E coli-derived asparaginase, the agency conducted intravenous administration trial at ten centres and evaluated 24 patients for the primary endpoint.
Earlier, Erwinaze was administered through intramuscular injection, while the current approval enables directing patients by either intravenous infusion or intramuscular injection in conjunction with chemotherapy.