JAZZ - Jazz wins FDA approval of Rylaze as part of chemo treatment for leukemia/ lymphoma

Pornpak Khunatorn/iStock via Getty Images The FDA granted approval to Jazz Pharmaceuticals' (JAZZ) Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as part of a chemotherapy regimen for acute lymphoblastic leukemia or lymphoblastic lymphoma. The approval is for patients one month and older who are hypersensitivity to E. coli-derived asparaginase. Rylaze was given Fast Track and orphan drug designations. Approval was based on the results of a phase 2/3 single-arm, open-label trial that included 102 patients. The company said Rylaze will be available beginning in mid-July. The FDA said that there has been a shortage of the only other drug available for this indication since 2016. Jazz shares were up 4.1% to $184.97 in after-hours trading.

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Jazz wins FDA approval of Rylaze as part of chemo treatment for leukemia/ lymphoma