FDA has approved asparaginase erwinia chrysanthemi (recombinant) for leukaemia and lymphoma

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August 2021: The Food and Drug Administration has approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as part of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adults and children aged one month and up who have developed hypersensitivity to E. coli-derived as

The efficacy of JZP458-201 (NCT04145531), an open-label, multi-cohort, multicenter trial in 102 patients with ALL or LBL who had hypersensitivity to E. coli-derived asparaginase as part of a multi-agent chemotherapy regimen, was examined. The average age was ten years, with a range of one to twenty-four years. Rylaze was administered intramuscularly in varied dosages to the patients.

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The achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL was the primary effectiveness outcome measure. Modeling and simulations revealed that with a dosage of 25 mg/m2 injected intramuscularly every 48 hours, 93.6 percent of patients maintained an NSAA of less than 0.1 U/mL 48 hours following a dose of Rylaze (95 percent CI: 92.6 percent , 94.6 percent ).

Abnormal liver tests, nausea, musculoskeletal pain, exhaustion, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycemia were the most prevalent side effects (incidence > 20%).

The suggested dosage of Rylaze when replacing a long-acting asparaginase product is 25 mg/m2 taken intramuscularly every 48 hours for the needed length of asparaginase activity.

 

Reference: https://www.fda.gov/

Check details here.

 

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