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Jazz Pharmaceuticals Announces Initiation of Biologics License Application Submission for JZP-458 for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program DUBLIN, Dec. 21, 2020 /PRNewswire/ -- Jazz
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program\n\n\nDUBLIN, Dec. 21, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has initiated the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for JZP-458 for use 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 who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. \n\n \n \n \n \n \n \n\n \nThe BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. \n\"Given the urgent need for a reliable and high-quality recombinant asparaginase option for patients with hypersensitivity to E. coli-derived asparaginase, we are committed to bringing JZP-458 to market as quickly as possible and pleased to be initiating our BLA submission,\" said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. \"Receiving a Fast Track designation for JZP-458 from the FDA in October 2019 and being able to submit the BLA under the RTOR program is significant, potentially allowing us to more quickly address patient need with a new asparaginase option.\" \nThe company continues to plan for a mid-2021 launch of JZP-458 following completion of the BLA submission and FDA review and approval.\nAn ongoing Phase 2/3 study is being conducted in collaboration with the Children's Oncology Group (COG) to evaluate JZP-458 as a potential treatment option for pediatric and adult patients with ALL or LBL who are hypersensitive to E. coli-derived asparaginases. Hypersensitivity reactions affect up to 30 percent of patients with ALL and LBL who are treated with E. coli-derived asparaginase.1 \nAbout JZP-458JZP-458 is a recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute ...