The European Commission has approved Jazz Pharmaceuticals' Enrylaze® for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma treatment

Jazz Pharmaceuticals plc has proclaimed that the EC has approved the commercialization of Enrylaze®(JZP458; a derivative of Erwinia asparaginase or crisantaspase). This treatment forms part of a compound chemotherapy program aimed at addressing acute lymphoblastic leukemia and lymphoblastic lymphoma in both adults and children.

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Enrylaze, granted approval and marketed as Rylaze® in both the U.S and Canada, is an innovative asparaginase derived from Erwinia, formulated via advanced recombinant technology. Its safety indicators align with other asparaginase preparations. 

Asparaginase is a principal ingredient in the blend of drugs used for ALL chemotherapy. However, up to one-third of patients build a hypersensitivity to the variety of asparaginase derived from E. coli, leading to treatment deferral or interruption,” stated Professor Carmelo Rizzari, who is in charge of the Pediatric Hematology Oncology Unit and is from the Department of Pediatrics, University of Milano-Bicocca. 

Robert Iannone, MD., M.S.C.E., the executive VP and global head of R&D at Jazz Pharmaceuticals, expressed that the acceptance of their application reflects Jazz’s dedication towards creating Erwinia-derived asparaginase using revolutionary recombinant technology for providing a consistent supply. He also conveyed their eagerness to make Enrylaze accessible to those requiring it. 

The endorsement from the EC primarily relied on findings from a joint Phase 2/3 trial carried out with the Children's Oncology Group, involving 228 individuals, both child and adult patients suffering from ALL and LBL, who had formed hypersensitivity or silent inactivation to E. coli-derived asparaginase. The assessment was executed in two stages examining the IV and IM delivery methods..

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According to the data provided by the Synapse Database, As of September 28, 2023, there are 17 investigational drugs for the ASN target, including 17 indications,31 R&D institutions involved, with related clinical trials reaching 237，and as many as 52139 patents.

Crisantaspase is a medicinal compound formulated by Jazz Pharmaceuticals Plc which operates on the principle of enzyme activity. Its main objective is ASN and primarily finds usage in combating neoplasms, disorders of the immune system, and diseases affecting the blood and lymphatic systems. The therapy has secured approval for its application in treating adult lymphoblastic lymphoma and acute lymphoblastic leukemia. It was first given the regulatory nod in Japan in December 2016 and has bagged regulatory titles such as Fast Track and Orphan Drug.