The FDA said it has approved Jazz Pharmaceuticals' Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as part of a multi-agent chemotherapeutic regimen to treat acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma (LBL) in adult and paediatric patients one month and older who are hypersensitive to E. coli-derived asparaginase. The company expects Rylaze will be commercially available in mid-July.
According to Jazz, Rylaze is the only recombinant erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire treatment course. The company noted that its product, previously known as JZP458, was developed to provide "an innovative, high-quality erwinia-derived asparaginase with reliable supply."
The marketing application for Rylaze, initiated by Jazz last December, was reviewed under the FDA's Real-Time Oncology Review (RTOR) pilot programme. Efficacy was evaluated in the Phase II/III study of 102 ALL or LBL patients who have had an allergic reaction to E. coli-derived asparaginases and have not previously received asparaginase erwinia chrysanthemi. Participants received Rylaze intramuscularly at various dosages as a component of a multi-agent chemotherapeutic regimen.
Approval was based on data from the first of three cohorts, which demonstrated the achievement and maintenance of nadir serum asparaginase activity (NSAA) ≥0.1 U/mL. According to the FDA, results of modeling and simulations showed that for a dosage of 25 mg/m2 administered every 48 hours, the proportion of patients maintaining NSAA ≥ 0.1 U/mL at 48 hours after a dose of Rylaze was 93.6%. Some of the most common adverse reactions occurring in more than 20% of patients were abnormal liver tests, nausea, musculoskeletal pain, febrile neutropenia, stomatitis, bleeding and hyperglycemia.
"We are pleased Rylaze was approved before the trial is complete and are diligently working to advance additional clinical trial data," said Jazz CEO Bruce Cozadd. The company cited recent data from the Children's Oncology Group retrospective analysis of over 8000 patients indicating that those who did not receive a full course of asparaginase treatment due to associated toxicity had significantly lower survival outcomes, regardless of whether they were high risk or standard risk, slow early responders.
Rylaze was granted orphan drug designation for the treatment of ALL/LBL by FDA in June.
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