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Approval Alert: AbbVie’s Tepkinly® (epcoritamab) Receives Conditional MA to Treat R/R DLBCL From EC

Sep 25, 2023

AbbVie announced that the EC granted conditional marketing authorisation for Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly® was co-developed by AbbVie and Genmab, and the companies share commercial responsibilities in the US and Japan.  AbbVie is responsible for further global commercialization and will continue to pursue regulatory submissions for the drug in international markets throughout 2023.