Jazz Pharmaceuticals plc JAZZ announced that the FDA has granted approval to a biologics license application (BLA) seeking approval of its novel asparaginase, Rylaze (JZP-458). The drug will likely be available from mid-July as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients (aged one month or more) who are hypersensitive to E. coli-derived asparaginase products.
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