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July 1, 2021Rylaze Approved to Treat ALL and LBL in Patients Allergic to E. Coli-Derived Chemotherapy Component
June 30, 2021 – The U.S. FDA has approved RylazeTM [asparaginase erwinia chrysanthemi (recombinant)- rywn], manufactured by Jazz Pharmaceuticals, for use as a chemotherapy component to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients who are at least one month old and are allergic to E. coli-derived asparaginase products. There is only one other FDA-approved drug for patients who have this allergy, and it has been in global shortage for years.
ALL is the most common childhood cancer, with pediatric patients accounting for roughly half of the 5,700 cases diagnosed annually. LBL is a rare cancer that shares characteristics with ALL, and treatment for the two diseases is often similar. This may include asparaginase, an enzyme that can kill cancer cells, as part of a chemotherapy regimen. Asparaginase breaks down an amino acid that the cancer cells need to survive. Though the enzyme is usually derived from E. coli, an estimated 20% of patients are allergic and need an alternative derived from another source.
Under recommended dosing, Ryalze should be administered via intramuscular injection every 48 hours at a dose of 25mg/m 2 of the patient’s body surface area. Patients treated at this dose in a clinical study achieved and maintained a target nadir serum asparaginase activity of at least 0.1 U/mL at 48 hours. In addition, Rylaze should be administered in a setting where medical support is available to appropriately manage anaphylactic reactions if they occur.
Jazz Pharmaceuticals has lunched the product at a wholesale acquisition cost (WAC) of $4,390 per single- dose vial.