Shots:

• The EMA submission is based on P-III ‘1053’ study results assessing Lumoxiti monothx in patients with r/r HCL who have received at least two prior therapies- including one purine nucleoside analog across 34 sites in 14 countries evaluating its safety- efficacy- and tolerability  
• The study resulted in 36% durable CR with hematological remission maintained for at least 180 days and 75% ORR- 81% of patients with CR experienced eradication of minimal residual disease- 61% can maintain it for five years who achieved CR
• Lumoxiti is CD22-directed immunotoxin and has received the US FDA’s approval in Sept 2018 with Orphan Drug designation by the FDA and EMA for r/r HCL. AstraZeneca holds BLA for Lumoxiti in the US with MAA in EU. In 2018- Innate in-licensed Lumoxiti from AstraZeneca- post-approval in the US in Sep 2019

Click here to read full press release/ article | Ref: Innate Pharma | Image: Signbox