FDA D.I.S.C.O. Burst: FDA approval of Rylaze
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Recently we have a quick update on another recent FDA cancer drug approval.
On June 30, 2021, the FDA approved asparaginase erwinia chrysanthemi (recombinant)-rywn (brand name Rylaze) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
Efficacy was evaluated in an open-label, multi-cohort, multicenter trial in 102 patients with acute lymphoblastic leukemia and lymphoblastic lymphoma with hypersensitivity to E. coli-derived asparaginase as a component of a multi-agent chemotherapeutic regimen. The median age was 10 years with a range of 1 to 24 years. Patients received Rylaze intramuscularly at various dosages.
The main efficacy outcome measure was demonstration of the achievement and maintenance of nadir serum asparaginase activity or NSAA above the level of 0.1 U/mL. The results of modeling and simulations showed that for a dosage of 25 mg/m2 administered intramuscularly every 48 hours, the proportion of patients maintaining NSAA ≥ 0.1 U/mL at 48 hours after a dose of Rylaze was 93.6%.
The most common adverse reactions with an incidence of greater than 20%, were abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycemia.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada.
This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 10 months ahead of the FDA goal date.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatfda.
Healthcare professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. And thanks for tuning into the D.I.S.C.O. Burst Edition.
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