Jazz Posts New Data for ALL/LBL Treatment At ASH 2021 Annual Meeting

Jazz Pharmaceuticals plc JAZZ revealed initial positive results from a Phase 2/3 trial of intramuscular (IM) administration of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) in acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL).
In Cohort 1c, a dosing regimen of Rylaze administered 25 mg on Monday and Wednesday and 50 mg on Friday demonstrated a favorable benefit-to-risk profile, showing that Rylaze maintains a clinically meaningful level of nadir serum asparaginase activity at both 48 and 72 hours.
The FDA approved Rylaze for use as a component of a multi-agent chemotherapeutic regimen for ALL or LBL in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase.
The data will support additional regulatory filings for Rylaze, including a supplemental marketing application in early 2022 for IM dosing schedule and support regulatory submissions in Europe in mid-2022, with potential for approval in 2023.
A separate arm of the ongoing Phase 2/3 study will be analyzed to support the dose and schedule for the intravenous (IV) route of administration for Rylaze.
Price Action: JAZZ shares closed at $122.72 on Friday.
Check out our coverage of the American Society of Hematology (ASH) Annual Meeting 2021 here.