AstraZeneca’s Lumoxiti Receives FDA approval for the Treatment of R/R 2L+ Hairy Cell Leukemia in patients

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

Click here to read full press release/ article | Ref: AstraZeneca | Image: The News Journal