Positive Opinion Issued for JZP458

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Marketing Authorization for JZP458 for its use as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and children (one month and older) who developed hypersensitivity or silent inactivation to Escherichia coli-derived asparaginase.

JZP458 is a recombinant Erwinia asparaginase or crisantaspase that uses a Pseudomonas fluorescens expression platform, according to Jazz Pharmaceuticals, the manufacturer of JZP458.

The CHMP’s recommendation is expected to be reviewed by the European Commission, which will make a final decision soon, according to Jazz Pharmaceuticals.

Source: Jazz Pharmaceuticals, July 2023