BRIEF—AbbVie and Genmab announce regulatory updates for epcoritamab

27 November 2023

Today, US drug major AbbVie and Denmark’s Genmab announced regulatory updates from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL).

Firstly, the FDA has granted Breakthrough Therapy designation (BTD) to Epkinly (epcoritamab-bysp). BTD may expedite the development and review of investigational medicines by the FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.
Additionally, the EMA has validated a Type II variation application for Tepkinly (epcoritamab). The EMA validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

These regulatory applications were supported by previously announced results from the Phase I/II EPCORE NHL-1 clinical trial, an open-label, multicenter safety and preliminary efficacy study evaluating subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including FL.