The CHMP has recommended granting conditional marketing authorisation for epcoritamab as a single agent for this indication following two or more lines of systemic therapy.
The overall response rate, evaluated by an independent review committee, was the trial’s primary endpoint.
AbbVie haematology therapeutic area head and vice-president Mariana Cota Stirner stated: “We are pleased with the recent CHMP positive opinion for epcoritamab, as it represents an important step in our journey to develop a potential core therapy for people living with B-cell malignancies, such as DLBCL.”
Epcoritamab is currently awaiting approval in the European Union (EU). Once approved, it will be marketed under the brand name TEPKINLY in all EU member states and in Iceland, Norway and Liechtenstein.
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