Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
The European Commission on Monday signed off on the expansion of AbbVie and Genmab’s bispecific antibody Tepkinly (epcoritamab) for the treatment of adult patients with relapsed or refractory follicular lymphoma.
The label expansion, granted under the European Commission’s (EC) conditional approval pathway, allows Tepkinly to be administered as a monotherapy in patients who have undergone at least two prior lines of therapy. Tepkinly’s conditional authorization will be valid for one year but can be renewed annually.
AbbVie and Genmab will need to provide additional data confirming that Tepkinly’s benefits in this indication outweighs its risks to secure standard marketing authorization for the drug.
Mariana Cota Stirner, vice president and therapeutic area head for hematology at AbbVie, in a statement called the European approval of Tepkinly “another step forward” in the company’s mission to establish the bispecific antibody “as a potential core therapy across multiple B-cell malignancies.”
Tepkinly’s “expansion into follicular lymphoma underscores its utility as a hematological cancer treatment,” Stirner said.
Designed to be injected subcutaneously, Tepkinly is a bispecific antibody that binds to both the CD3 receptor on T cells and the CD20 protein typically found on the surface of B-cells. This mechanism of action allows Tepkinly to activate T cells, inducing the release of proinflammatory cytokines and facilitating the destruction of malignant B cells.
The molecule was first developed by Genmab, which in June 2020 received $750 million upfront and the potential for$3.5 billion in biobucks from AbbVie to jointly advance and commercialize the therapy.
Tepkinly won its first European approval in February 2022 for the third-line treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Monday’s label expansion makes Tepkinly the “first and only” EC-approved subcutaneous bispecific T cell engager indicated for both relapsed or refractory follicular lymphoma (FL) or DLBCL, according to AbbVie.
In the U.S., AbbVie and Genmab’s epcoritamab is sold under the brand name Epkinly, which won its first FDA approval in May 2023 for relapsed or refractory DLBCL. Its FL indication came in June 2024.
The EC’s decision on Monday was backed by data from the Phase I/II EPCORE NHL-1 study, which enrolled patients who were refractory to an anti-CD20 monoclonal antibody and an alkylating agent. The trial demonstrated an overall response rate of 83%, with a complete response rate of 63%. The median duration of response was 21.4 months.
In terms of safety, EPCORE NHL-1 found Tepkinly’s adverse event profile to be consistent with what had been established in prior cohorts. Common side effects included injection site reaction, fatigue, muscle pain and neutropenia. Fourteen patients died of adverse reactions.
