Application submission for JZP 458 for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma.- Jazz Pharmaceuticals.

Jazz Pharmaceuticals plc announced that the company has initiated the submission of a Biologics License Application (BLA) to the 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. The 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. The company continues to plan for a mid-2021 launch of JZP 458 following completion of the BLA submission and FDA review and approval. An ongoing Phase II/III 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.