FDA Approves Rylaze for Certain Patients with Leukemia and Lymphoma


The FDA approval provides patients with an alternative therapy to the only other approved treatment, which has been under a global shortage for several years.

The Food and Drug Administration (FDA) approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn) to be used as a component of a chemotherapy regimen in the treatment of adults and children with acute lymphoblastic leukemia and lymphoblastic lymphoma who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.

Of note, the approval helps combat a global shortage of the only other FDA-approved drug for this specific patient population.

“It is extremely disconcerting to patients, families and providers when there is a lack of access to critical drugs for treatment of a life-threatening, but often curable cancer, due to supply issues,” said Dr. Gregory Reaman, associate director for pediatric oncology in the FDA’s Oncology Center of Excellence, in an agency-issued news release. “Today’s approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia.”

Approximately 20% of the 5,700 patients diagnosed with this disease are allergic to the standard E. coli-derived asparaginase and need other tolerable therapies.

The FDA based its decision on data from a study of 102 patients who either had a hypersensitivity to E. coli-derived asparaginases or experienced silent inactivation to treatment. The results demonstrated that treatment with the recommended dose of Rylaze provided the target level of asparaginase activity in 94% of patients.

Hypersensitive reactions, pancreatic toxicity, blood clots, hemorrhage and liver toxicity were some of the more common side effects associated with treatment.

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