Written by Modality Solutions
Posted on: July 26, 2021
DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older. Rylaze was granted orphan drug designation for the treatment of ALL/LBL by FDA in June 2021. The Biologics Licensing Application (BLA) approval followed review under the Real-Time Oncology Review (RTOR) program, an initiative of FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients. Approval under U.S. FDA’s Real-Time Oncology Review program represents an important therapeutic advance for pediatric and adult patients who develop hypersensitivity to E. coli-derived asparaginase treatments. Rylaze is expected to become commercially available in the U.S. in mid-July, 2021. (source: Jazz Pharmaceuticals press release)
Modality Solutions works with biopharma innovators like Jazz Pharmaceuticals to ensure their cold chains are ready for regulatory filing success. Many of our client’s clinical trials are being conducted under special FDA designations, including as part of the Orphan Drug Development Program.