AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by preliminary results from a Phase I/II study assessing the safety and preliminary efficacy of the T-cell engager in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including FL.
Earlier this year, the subcutaneous injection received approval in Europe and the US for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). AbbVie, in collaboration with partner Genmab (NASDAQ: GMAB), is advancing the development of Tepkinly/Epkinly as a monotherapy and in combination with other treatments for both DLBCL and FL.- Flcube.com
