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HomeLatest Pharma-NewsOnly treatment approved in the US for relapsed or refractory hairy cell...

Only treatment approved in the US for relapsed or refractory hairy cell leukemia Approved by FDA at ASH 2019

Dec. 08, 2019: Innate Pharma shared new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox-tdfk) at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, USA. 

The final analysis showed that 36 percent (29/80) of the relapsed or refractory hairy cell leukemia patients achieved strong response (CR) with Lumoxiti at Day 181 of patient’s respective evaluation as compared to the primary analysis in which 30 percent durable CR rate was reported.

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Also, there was a 61 percent probability of the patients who achieved a CR would maintain it after five years.

The single-arm, multi-center, open-label Phase III ‘1053’ clinical trial assessed the efficiency, safety, immunogenicity and pharmacokinetics of Lumoxiti monotherapy in 80 patients with relapsed or refractory hairy cell leukemia who had already received at least two prior therapies, including one purine nucleoside analog. https://fda.einnews.com/pr_news/504317616/innate-pharma-highlights-fda-approved-lumoxiti-at-ash-2019

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