Shots:

• The sBLA submission was based on the three-cohort of the P-II/III trial to evaluate Rylaze (25/37.5 mg/m2 in cohort 1a & 1b, 25 mg/m2 in cohort 1c, MWF, IM, dosing schedule) in adult & pediatric patients with ALL and LBL
• The results demonstrated a positive benefit-to-risk profile, patients treated with Rylaze maintain a level of NSAA ≥0.1 IU/mL at both 48 & 72hrs. & the safety profile was consistent with the reported safety profile for patients with ALL/LBL receiving asparaginase with combination CT
• The submission will be reviewed under FDA's RTOR program. Rylaze has received ODD for the treatment of ALL/LBL in June 2021 and was added to NCCN Guidelines in July 2021

Ref: PR Newswire | Image: Biospace