AbbVie announces European Commission approval for Tepkinly for second indication

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 follicular lymphoma after two or more lines of prior therapy. Tepkinly is “the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R diffuse large B-cell lymphoma in the European Union, as well as the European Economic Area countries and Northern Ireland,” the company stated. “The European approval of Tepkinly for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop Tepkinly as a potential core therapy across multiple B-cell malignancies. First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a hematological cancer treatment,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “Together with our partner, Genmab, we are thrilled with today’s approval which advances our commitment to elevating care for people living with cancer.”