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FDA Approvals, News & UpdatesLeukemiaLymphoma

FDA Approved Rylaze as Part of a Treatment Regimen for Young Patients with Leukemia or Lymphoma

In June 2021, the FDA approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), an asparagine-specific enzyme, to be used as part of a multi-drug chemotherapy regimen for patients older than 1 month with acute lymphoblastic leukemia or lymphoblastic lymphoma who are hypersensitive to asparaginase caused by E. coli infection.
August 2021 Vol 7 No 4

On June 30, 2021, the FDA accelerated the approval of Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn; from Jazz Pharmaceuticals), an asparagine-specific enzyme, to be used as part of a multi-drug chemotherapy regimen for the treatment of young patients (older than 1 month) with acute lymphoblastic leukemia or lymphoblastic lymphoma who are hypersensitive to asparaginase caused by Escherichia coli infection.

The FDA accelerated the approval of Rylaze to address the current shortages of a similar drug, Erwinaze (erwinia asparaginase). The ongoing shortages of Erwinaze have been “incredibly stressful to patients and their parents,” said Sumit Gupta, MD, PhD, University of Toronto, and Pediatric Oncologist, Hospital for Sick Children, Toronto, Canada.

Rylaze “has the same molecular makeup as Erwinaze. But it’s manufactured differently, and in a more efficient way, so having the option to substitute Rylaze should reduce the likelihood of treatment shortages for these patients in the future,” said Malcolm A. Smith, MD, PhD, Associate Branch Chief for Pediatric Oncology, NCI’s Cancer Therapy Evaluation Program.

Rylaze can be used as a substitute to Erwinaze in patients with an immune reaction to pegaspargase.

The FDA approved Rylaze based on results of a clinical trial that included 102 young patients (aged 1 to 24 years) with acute leukemia or lymphoma who had hypersensitivity to asparaginase caused by E. coli infection.

The most common side effects with Rylaze were abnormal liver test results, nausea, musculoskeletal pain, fatigue, infection, headache, fever, febrile neutropenia, reduced appetite, stomatitis, bleeding, and hyperglycemia.

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Last modified: September 2, 2021

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