Shots:

• The approval is based on P-III ‘1053’ trial conducted across 34 sites in 14 countries assessing Lumoxiti (moxetumomab pasudotox-tdfk) in patients with r/r HCL- testing its safety- efficacy- immunogenicity and PK
• P-III ‘1053’ trial (N=80) results: ORR (75%); DOR (30%); CR (41%); PRR (34%); hematologic remission rate (80%)
• Lumoxiti (CD22-directed cytotoxin) novel treatment in US for r/r HCL with recommended IV dose 0.04 mg/kg given over 30mins on days 1- 3 & 5 of each 28-day cycle up to 6 cycles- disease progression- or unacceptable toxicity

 Ref: AstraZeneca | Image: AstraZeneca