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FDA Approves Chemo Component for Treatment of Patients With ALL
On June 30, 2021, the FDA approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals) as a component of a chemotherapy regimen for the treatment of adults and young patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma who are allergic to E. coli-derived asparaginase products, which are commonly used for treatment.
The FDA said the only other drug approved for these patients has experienced a global shortage in recent years.
“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. 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,” said Gregory Reaman, MD, Associate Director for Pediatric Oncology, Oncology Center of Excellence, FDA.
The approval was based on a study of 102 patients that had either a hypersensitivity to E. coli-derived asparaginases or experienced silent inactivation.
The main measurement was whether patients achieved and maintained a certain level of asparaginase activity. Results showed that the recommended dosage would provide the target level of asparaginase activity in 94% of patients.
The most common adverse events (AEs) in patients receiving asparaginase erwinia chrysanthemi (recombinant)-rywn were hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity.
The FDA also said it granted fast track and orphan drug designations to asparaginase erwinia chrysanthemi (recombinant)-rywn for this indication.—Emily Bader
