FDA Approves Rylaze for Patients with Leukemia Experiencing Allergic Reactions to Asparaginase Treatment

FDA Approves Rylaze for Patients with Leukemia Experiencing Allergic Reactions to Asparaginase Treatment

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​ FDA Approves Rylaze for Patients with Leukemia Experiencing Allergic Reactions to Asparaginase Treatment

On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved Rylaze for use in combination with multiple chemotherapy drugs for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who experienced allergic reactions to asparaginase treatment.

This approval was based on the evaluation from the JZP458-201 (NCT04145531) trial, a multicenter, non-blinded, open-label trial. Asparaginase is one of the agents used in combination with multiple chemotherapy regimens for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma. In this trial, 102 patients who experienced allergic reactions to asparaginase were treated with Rylaze via intramuscular injection, with a median age of 10 years (ranging from 1 to 24 years).

The primary endpoint was serum asparaginase activity (ASP) increasing from the nadir by at least 0.1 U/mL and being maintained. Trial results and simulation data showed that approximately 93.6% of patients achieved serum ASP ≥0.1 U/mL 48 hours after intramuscular injection of Rylaze 25 mg/m² every 48 hours.

The main adverse effects of Rylaze (occurring in ≥20% of patients) include abnormal liver function, nausea, musculoskeletal pain, fatigue, infection, headache, fever, drug allergies, febrile neutropenia, loss of appetite, stomatitis, bleeding, and hyperglycemia.

When switching from long-acting asparaginase to Rylaze, it is recommended to administer Rylaze 25 mg/m² via intramuscular injection every 48 hours to maintain asparaginase activity.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma?utm_medium=email&utm_source=govdelivery

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