The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of preliminary Phase I/II data that demonstrated the biologic’s efficacy and safety profile.
Clinical Trial Results and EC Approval
The EC’s approval was based on compelling preliminary data from a Phase I/II study, which showed Tepkinly achieved an overall response rate (ORR) of 62%, a complete response rate (CRR) of 39%, and a median duration of response of 15.5 months. These results highlight the potential of Tepkinly in improving outcomes for patients with R/R DLBCL, a type of non-Hodgkin lymphoma that is aggressive and often difficult to treat.
Collaboration and Commercialization
In line with the collaboration agreement between AbbVie and Genmab (CPH: GMAB), the two companies will share commercial responsibilities for Tepkinly in the markets of Japan and the US. This partnership underscores the global reach and strategic importance of Tepkinly in addressing the unmet needs of patients with DLBCL.-Fineline Info & Tech
