EMA accepts regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukaemia

Innate Pharma

2 January 2020 - Innate Pharma today announced that the EMA has accepted the marketing authorisation application for Lumoxiti (moxetumomab pasudotox-tdfk), a first-in-class medicine indicated for adult patients with relapsed or refractory hairy cell leukaemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

The EMA filing is based on the final analysis of the pivotal Phase III trial of Lumoxiti, presented at ASH 2019.

Read Innate Pharma press release  

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Cancer , Medicine , Europe , Dossier