Innate’s Lumoxiti (moxetumomab pasudotox-tdfk) Receives EMA’s MAA to Treat Patients with Relapsed or Refractory Hairy Cell Leukemia

 Innate’s Lumoxiti (moxetumomab pasudotox-tdfk) Receives EMA’s MAA to Treat Patients with Relapsed or Refractory Hairy Cell Leukemia

Innate’s Lumoxiti (moxetumomab pasudotox-tdfk) Receives EMA’s MAA to Treat Patients with Relapsed or Refractory Hairy Cell Leukemia

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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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