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WILLINGTON, England, May 10, 2021 /PRNewswire/ Bionical Emas, a global specialist Clinical Research Organization (CRO), has today announced the launch of a U.S. Expanded Access Program for Jazz Pharmaceuticals investigational therapy JZP458 (asparaginase
Erwinia chrysanthemi (recombinant)) for the treatment of adult and pediatric patients with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) following hypersensitivity or silent inactivation to
E. coli-derived asparaginases. JZP458 is currently under FDA review for marketing authorization in the United States. The Expanded Access Program (EAP) provides a mechanism to fulfill unsolicited physician requests in the U.S. and support the special need of a patient.
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WILLINGTON, England, April 8, 2021 /PRNewswire/ Bionical Emas, a global specialist Clinical Research Organization (CRO) has today announced the launch of a Managed Access Program for Jazz Pharmaceuticals medicinal product JZP-458 for the treatment of patients with Acute Lymphoblastic Leukaemia (ALL) and Lymphoblastic Lymphoma (LBL) following hypersensitivity to E. Coli-derived asparaginases. The Managed Access Program provides a mechanism through which unsolicited physician requests, to fulfil the special need of a patient can be supported.
JZP-458 provides a further therapy option for paediatric and adult patients with ALL or LBL who have not tolerated certain asparaginase treatments and currently have limited treatment options, and we re pleased to support this program, said