AbbVie announces European Commission approval of TEPKINLY

AbbVie (ABBV) announced that the European Commission has granted conditional marketing authorization for TEPKINLY as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union, as well as Liechtenstein, Norway and Iceland. TEPKINLY is being co-developed by AbbVie and Genmab (GMAB) as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.