JAZZ - Jazz Pharmaceuticals files for US approval of new dosing schedule of Rylaze

Jazz Pharmaceuticals (JAZZ -0.5%) completed the submission of a supplemental biologics license application to the U.S. Food and Drug Administration seeking approval for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze for use as a component of a multi-agent chemotherapeutic regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. The submission will be reviewed under the Real-Time Oncology Review (RTOR) program and follows Rylaze's (asparaginase erwinia chrysanthemi (recombinant)-rywn) initial approval under the RTOR program in June 2021. "With a dosing schedule of Rylaze administered 25/25/50 mg/m2 on Monday/Wednesday/Friday, patients maintain a clinically meaningful level of nadir serum asparaginase activity through the entire duration of treatment. We look forward to submitting two additional regulatory applications this year to ensure as many patients as possible can have access to a reliable and high-quality supply of this important therapy, including

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Jazz Pharmaceuticals files for US approval of new dosing schedule of Rylaze