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FDA Approves Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn for Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma

Evidence for efficacy is based on the results from the Study JZP458-201
13 Jul 2021
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 30 June 2021, the US Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

Efficacy was evaluated in Study JZP458-201 (NCT04145531), an open-label, multi-cohort, multicentre study in 102 patients with ALL or LBL with hypersensitivity to E. coli-derived asparaginase as a component of a multi-agent chemotherapeutic regimen. The median age was 10 years with a range of 1 to 24 years. Patients received Rylaze intramuscularly at various dosages. 

The main efficacy outcome measure was demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL. The results of modelling and simulations showed that for a dosage of 25 mg/m2 administered intramuscularly every 48 hours, the proportion of patients maintaining NSAA ≥ 0.1 U/mL at 48 hours after a dose of Rylaze was 93.6% (95% confidence interval 92.6%, 94.6%).

The most common adverse reactions (incidence > 20%) were abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycaemia.

When replacing a long-acting asparaginase product, the recommended dosage of Rylaze is 25 mg/m2 administered intramuscularly every 48 hours for the required duration of asparaginase activity.

Full prescribing information for Rylaze is available here.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada.

This review used the Real-Time Oncology Review pilot programme, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 10 months ahead of the FDA goal date.

This application was granted fast track and orphan drug designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate.

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