CHMP recommends JZP 458 as a component for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma.-Jazz Pharma
Jazz Pharmaceuticals plc announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization of JZP 458(Enrylaze) (a recombinant Erwinia asparaginase or crisantaspase) 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 pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
JZP 458 is a recombinant Erwinia asparaginase or crisantaspase that uses a Pseudomonas fluorescens expression platform. It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who developed hypersensitivity to E. coli-derived asparaginase products. JZP 458 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.
The benefit of Enrylaze is the achievement and maintenance of nadir (minimal) serum asparaginase activity, which has been demonstrated to correlate with serum asparagine depletion. The most common side effects are anaemia, vomiting, thrombocytopenia, neutropenia, nausea, febrile neutropenia, fatigue and pyrexia.
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