FDA Approves Chemotherapy Option for Common Childhood Cancers
The US Food and Drug Administration (FDA) has approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma.
The drug is approved for use in adult and pediatric patients who are allergic to standard E. coli-derived asparaginase products. Approximately 20% of patients are allergic to the most commonly used treatment, but a global shortage of the only FDA-approved alternative has made treatment difficult for this patient population.
The approval was based on a study which indicated that the recommended dose of this new treatment option provided 94% of patients with the target level of asparaginase activity. Included in this study were 102 patients with either a hypersensitivity to E. coli-derived asparaginases or those who had experienced silent inactivation. Common side effects include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity.
“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,” concluded FDA officials. “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.”
FDA approved component of treatment regimen for most common childhood cancer. News release. US Food and Drug Administration; June 30, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-component-treatment-regimen-most-common-childhood-cancer?utm_medium=email&utm_source=govdelivery