The FDA approval provides patients with an alternative therapy to the only other approved treatment, which has been under a global shortage for several years.
The Food and Drug Administration (FDA) approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn) to be used as a component of a chemotherapy regimen in the treatment of adults and children with acute lymphoblastic leukemia and lymphoblastic lymphoma who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.
Of note, the approval helps combat a global shortage of the only other FDA-approved drug for this specific patient population.
“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 Dr. Gregory Reaman, associate director for pediatric oncology in the FDA’s Oncology Center of Excellence, in an agency-issued news 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.”
Approximately 20% of the 5,700 patients diagnosed with this disease are allergic to the standard E. coli-derived asparaginase and need other tolerable therapies.
The FDA based its decision on data from a study of 102 patients who either had a hypersensitivity to E. coli-derived asparaginases or experienced silent inactivation to treatment. The results demonstrated that treatment with the recommended dose of Rylaze provided the target level of asparaginase activity in 94% of patients.
Hypersensitive reactions, pancreatic toxicity, blood clots, hemorrhage and liver toxicity were some of the more common side effects associated with treatment.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.