The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of JZP458 (a recombinant Erwinia asparaginase or crisantaspase).
It has been recommended for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (one month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
“Today’s positive CHMP opinion is welcome news for those in the ALL and LBL community who are unable to be treated with E. coli-derived asparaginase due to hypersensitivity reactions,” says Robert Iannone, Executive Vice President, Global Head of Research and Development of Jazz Pharmaceuticals. “We look forward to receiving the final decision that will help bring us one step closer to delivering a reliable supply of recombinant Erwinia asparaginase to patients in the European Union.”
The CHMP’s recommendation will now be reviewed by the European Commission (EC).
JZP458 is a recombinant Erwinia asparaginase or crisantaspase that uses a Pseudomonas fluorescens expression platform. It was approved by the US Food and Drug Administration (FDA) in June 2021 for the treatment of this patient population and became commercially available in July of the same year in the US.