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AbbVie: CHMP Adopts Positive Opinion Recommending Conditional Marketing Authorization Of Epcoritamab

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

AbbVie (ABBV) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of epcoritamab, the first T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more prior therapies. The European Commission decision on this indication is anticipated later in the current year.

Epcoritamab is being co-developed by AbbVie and Genmab. They will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

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