Posted by Michael Wonder on 22 Dec 2020
Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma
21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program.
Jazz Pharmaceuticals today announced that the company has initiated the submission of a biologics license application to the U.S. FDA seeking marketing approval for JZP-458 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma in adult and paediatric patients who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
