June 20, 2021 marked the approval of Rylaze (Asparaginase erwinia chrysanthemi (recombinant)-rywn) by the U.S. Food and Drug Administration (FDA). This is a part of the chemotherapy regime for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in adult and pediatric patients who are sensitive to frequently used asparaginase products derived from Escherichia coli, also called E. Coli.
This approvalmay be a reliable substitute to a critical part of the possibly curative therapy for people with leukemia, mentioned the associate director for pediatric oncology, FDA’s Oncology Center of Excellence.
About half of the total patients who suffer from acute lymphoblastic leukemia are children making it most common type of childhood cancer. One constituent of the chemo regime is an enzyme – asparaginase that destroys cancer cells by depriving them of materials required for survival. About 20% of patients are sensitive to the usual E. coli- obtained asparaginase and therefore need a substitute for the same.
The effectiveness of Rywn was studied in a total of 102 patients who were either hypersensitivity to asparaginases obtained from Escherichia coli or underwent silent inactivation. The key measurement was whether patients attained and sustained a definite level of asparaginase activity. As found, the suggested dosage would deliver the intended level of asparaginase activity in almost all the patients (94% of patients). Hypersensitivity reactions, pancreatic and liver toxicity, blood clots and hemorrhage were commonly observed adverse effects.
|Original title of the article:||FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer|