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AbbVie's extension of indication application for epcoritamab in 3L r/r FL under EMA evaluation

  • 1 dicembre 2023 - Newsletter n. 45 - Dicembre 2023
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AbbVie has announced that the EMA has validated its extension of indication application for Tepkinly (epcoritamab) for the treatment of adult patients with R/R FL after two or more therapies.

This submission is supported by the results from the Phase 1/2 EPCORE NHL-1 clinical trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including FL.

EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a Phase 2a dose optimization part

Reference link: AbbVie press release

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