New FDA approval means that pediatric and adult patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma who are allergic to the E. coli-derived asparaginase products can now be treated with asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as a component of a chemotherapy regimen.
Rylaze’s approval is supported by a study of 102 patients who were either hypersensitive to E. coli-derived asparaginases or experienced silent inactivation, the results of which showed that the recommended dose of Rylaze delivered the targeted level of asparaginase activity in 94% of patients. patients. patients.
“It is extremely distressing for patients, families and caregivers when there is a lack of access to critical drugs to treat a life-threatening, but often curable, cancer, due to delivery problems,” said Gregory Reaman, MD, associate director for pediatric oncology at the FDA’s Oncology Center of Excellence. “Today’s approval may provide a consistent alternative to a critical component of potentially curative therapy for children and adults with this type of leukemia.”
Rylaze’s review was conducted as part of Project Orbis, which is being conducted by the FDA’s Oncology Center of Excellence, which allows for simultaneous submission and review of oncology agents to global regulatory authorities. In this review, the FDA partnered with Health Canada. The application review for Rylaze in Canada is currently pending.
Previously, the only other FDA-approved drug for patients with these allergic reactions had a worldwide shortage since 2016, the agency said. Each year, ALL occurs in approximately 5,700 patients; about half of these are children, with ALL being the most common type of pediatric malignancy.
Asparaginase, part of the chemotherapy regimen, kills cancer cells by depriving them of the substances they need to survive. About 20% of patients are allergic to the standard E. coli-derived asparaginase and therefore require alternative treatment.
In terms of safety, the most common side effects of Rylaze are hypersensitivity reactions, pancreatic toxicity, blood clots, bleeding, and liver toxicity.
FDA Approves Part of Treatment Schedule for Most Common Childhood Cancer. news item. 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”