Posted by Michael Wonder on 24 Jul 2023
Jazz Pharmaceuticals receives CHMP positive opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 July 2023 - Jazz Pharmaceuticals today announced that the EMA's CHMP adopted a positive opinion recommending the marketing authorisation of JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
JZP458 was approved by the US FDA in June 2021 for the treatment of this patient population and became commercially available in July of the same year in the US.
