FDA Approves Rylaze as Alternative for Patients with ALL and Lymphoblastic Lymphoma

The FDA has approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as a complement of treatment for the most common childhood cancer.

New FDA approval means that pediatric and adult patients with acute lymphoblastic leukemia (ALL) and lympoblastic lymphoma who are allergic to the E. coli-derived asparaginase products, are now able to be treated with asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as part of a chemotherapy regiment.

The approval of Rylaze is supported by a study of 102 patients who either had a hypersensitivity to E. coli-derived asparaginases or experienced silent inactivation, results of which showed that the recommended dose of Rylaze provided the target level of asparaginase activity in 94% of patients.

"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 Gregory Reaman, MD, associate director for pediatric oncology in the FDA's Oncology Center of Excellence. "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."

The review of Rylaze was conducted under Project Orbis, which is conducted through the FDA's Oncology Center of Excellence, which allows for concurrent submission and review of oncology agents across global regulatory agencies. In this review, the FDA collaborated with Health Canada. The application review for Rylaze in Canada is currently pending.

Previously, the only other FDA-approved drug for patients who have these allergic reactions has been in a global shortage since 2016, the agency stated. Each year, ALL occurs in approximately 5700 patients; about half of these are children, in which ALL is the most common type of pediatric malignancy.

Asparaginase, which is 1 component of the chemotherapy regimen, kills cancer cells by depriving them of substances that are necessary for survival. Approximately 20% of patients are allergic to the standard E. coli-derived asparaginase, and therefore require need an alternative treatment.

Regarding safety, the most common adverse effects associated with Rylaze include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity.


FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer. News release. FDA. June 30, 2021. Accessed June 30, 2021. https://prn.to/3xe7rbi

This article was originally published on OncLive as “FDA Approves Rylaze for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma”