Posted by Michael Wonder on 02 Feb 2022
Jazz Pharmaceuticals completes U.S. FDA supplemental biologics license application for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Monday/Wednesday/Friday dosing schedule
2 February 2022 - Phase 2/3 trial data, the basis for submission, demonstrates Rylaze maintains a clinically meaningful level of nadir serum asparaginase activity throughout the entire duration of treatment for adult and paediatric patients with acute lymphoblastic leukaemia and lymphoblastic lymphoma.
Jazz Pharmaceuticals today announced that the Company has completed the submission of a supplemental biologics license application to the U.S. FDA seeking approval for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma in adult and paediatric patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase.
