Jazz Pharma Gets Positive CHMP Opinion For JZP458

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the marketing authorization of JZP458 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. The CHMP's recommendation will now be reviewed by the European Commission.

JZP458 was approved by the FDA in June 2021 for the treatment of this patient population and became commercially available in July of the same year in the U.S.

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