Shots:

• The approval is based on clinical data from an ongoing P-II/III JZP458-201 trial evaluating Rylaze in pediatric and adult patients aged ≥1mos. with ALL or LBL who are allergic to the E. coli-derived asparaginase. Rylaze has approved under the RTOR program
• Additionally- recent data from a Children's Oncology Group retrospective analysis in ~8-000 patients showed that the patients without asparaginase treatment due to associated toxicity had lower survival outcomes
• The therapy is expected to be commercially available in mid-July in the US. The FDA has granted ODD to Rylaze for ALL/LBL in June’21 & FTD in Oct’19

  | Ref: PR Newswire | Image: Life Sciences IP Review