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Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission (EC) has granted marketing
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission (EC) has granted marketing authorization for Enrylaze® (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.[1] Enrylaze, approved as Rylaze® in the United States and Canada, is a new Erwinia-derived asparaginase developed using a next-generation recombinant technology with a safety profile consistent with that of other asparaginase preparations.1,2,3,4,5\n\"Asparaginase is a core component of multi-agent chemotherapeutic regimens for the treatment of ALL, however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase, resulting in a delay or disruption in treatment,\" said Professor Carmelo Rizzari, Department of Pediatrics, University of Milano-Bicocca, Head of the Pediatric Hematology Oncology Unit, Foundation IRCCS San Gerardo dei Tintori, Monza, Italy. \"The ability to complete a full course of asparaginase treatment is of critical importance when treating ALL and LBL, as it is strongly linked to improved outcomes for patients. The approval of Enrylaze now provides an important option to support patients in completing their planned asparaginase treatment regimen.\"\nEnrylaze may be given by both intravenous infusion (IV) and intramuscular injection (IM) and is dosed on either alternate days (every 48 hours) or via a Monday/Wednesday/Friday (MWF) dosing schedule.1 The use of recombinant technology to manufacture Enrylaze delivers a scalable supply – able to meet global demand, and a ready-to-use solution that avoids the need for reconstitution in the clinic.2 \n\"This approval is a testament to Jazz's commitment to developing an Erwinia-derived asparaginase using innovative recombinant technology to deliver a scalable supply, and we look forward to making Enrylaze available to those who need it,\" said Robert Iannone, MD., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. \"Healthcare professionals in the European Union will now have...