FDA Approves Alternative to E. Coli–Derived Asparaginase for ALL

Approval of asparaginase erwinia chrysanthemi (recombinant)-rywn represents a long-awaited alternative to E. Coli–derived asparaginase for patients with acute lymphoblastic leukemia.

The FDA has granted approval to asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as an alternative component to chemotherapy Escherichia coli (E. coli)–derived asparaginase products in adult and pediatric patients with acute lymphoblastic leukemia.

This decision by the agency offers hope to about 20% of patients who are allergic to the standard E. coli-derived form of the drug and need alternative treatment options.

“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,” Gregory Reaman, MD, associate director for pediatric oncology in the FDA’s Oncology Center of Excellence, said in a press 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.”

Efficacy of asparaginase erwinia chrysanthemi (recombinant)-rywn was verified in a trial of 102 patients with hypersensitivity of or silent inactivation with the use of E. coli–derived asparaginase. The recommended dose of the agent was able to induce target levels of asparaginase activity in 94% of participants.

Common adverse events of therapy with asparaginase erwinia chrysanthemi (recombinant)-rywn included hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity.

Review of the product was conducted under Project Orbis, which allows simultaneous submission and review of oncology products by the FDA and international regulatory agencies. Previously, the agent was granted fast track and orphan drug designations for this indication.

Prior to the approval, there was a critically unmet need for non–E. coli-derived asparaginase agents due to a global shortage. The Escherichia carotovora–derived form of asparaginase is also used for cases of asparaginase hypersensitivity.


FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer. News release. FDA. June 30, 2021. Accessed June 30, 2021. https://bit.ly/363Ozjj