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European Commission Grants AbbVie Conditional Marketing Authorization for Epcoritamab to Treat Relapsed/Refractory Follicular Lymphoma in Adults

NextEdge Admin

20 Aug 2024

2 min 10 sec

European Commission,T-cell engaging bispecific antibody,AbbVie

AbbVie announced that the European Commission has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior therapies. Tepkinly is the first subcutaneous T-cell engaging bispecific antibody approved in the European Union and the European Economic Area for treating both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL).

The approval reflects Tepkinly's potential as a core therapy across multiple B-cell malignancies, following its initial approval for R/R DLBCL. Follicular lymphoma, a slow-growing non-Hodgkin’s lymphoma (NHL) from B-lymphocytes, accounts for 20-30% of NHL cases. It is incurable, with no standard treatment for third-line or later stages, often leading to relapse and transformation into aggressive DLBCL in over 25% of cases.

The conditional authorization is based on data from the phase 1/2 EPCORE NHL-1 trial, which showed an overall response rate of 83% and a complete response rate of 63% in patients treated with Tepkinly. With a median follow-up of 16.2 months, the median duration of response was 21.4 months. The study also included an optimization cohort for cytokine release syndrome (CRS) mitigation, where the optimized regimen showed manageable CRS with no severe cases reported.

This approval marks a significant step in providing new treatment options for patients with challenging forms of FL.