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Jazz Pharmaceuticals Receives CHMP Positive Opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
DUBLIN, July 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Medicines Agency's (EMA) Committee for
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"DUBLIN, July 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today 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 JZP458 (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.\n\"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, MD., M.S.C.E., 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.\"\nThe CHMP's recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all European Union Member States, Iceland, Norway, and Liechtenstein, and is expected to make a final decision soon.\nAbout Acute Lymphoblastic Leukemia (ALL)Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.1,2 ALL is the most common childhood malignancy, accounting for 80% of leukemia diagnoses in children, compared to 20% of adults.3 Long-term survival rates for pediatric patients have improved significantly over the last few decades.4 The estimated overall incidence of ALL and lymphoblastic lymphoma (LBL) in Europe is 1.28 per 100,000.5\nAsparaginase is a core component of multi-agent chemotherapeutic regimens in ALL,6 however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase,7 necessitating treatment discontinuation or a switch to a non-E. coli-derived asparaginase preparation.8 Patients not receiving asparaginase due to hypersensitivities and those not receiving all prescribed doses have been shown to have poor outcomes.9,10\nAbout Lymphoblastic Lymphoma (LBL)Lymphoblastic Lymphoma (LBL) is a rare...