BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - AbbVie (ABBV) and Genmab A/S (GMAB) announced Monday that the European Commission has granted conditional marketing authorization for TEPKINLY (epcoritamab) for adults with relapsed or refractory or R/R diffuse large B-cell lymphoma or DLBCL.
TEPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.
The approval is for TEPKINLY as a monotherapy for the treatment of adult patients with R/R DLBCL after two or more lines of systemic therapy.
Patients with DLBCL, the most common type of B-cell non-Hodgkin's lymphoma, face limited treatment options, with few readily available, off-the-shelf medicines, especially for those whose disease has relapsed or become refractory to prior treatments.
The companies noted that TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of patients with DLBCL in the European Union, as well as Liechtenstein, Norway and Iceland.
Conditional marketing authorization is granted to medicines that address an unmet medical need.
The conditional approval was supported by data from the pivotal EPCORE NHL-1 Phase 1/2 open-label, multi-cohort, multi-center, single-arm trial evaluating the preliminary efficacy and safety of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL.
In the study, DLBCL patients treated with TEPKINLY achieved an overall response rate of 62 percent and a complete response rate of 39 percent.
Roopal Thakkar, senior vice president, development and regulatory affairs, chief medical officer, AbbVie, said, 'The European Commission approval of epcoritamab represents a significant milestone in our aspiration with Genmab to develop a potential core therapy for patients with B-cell malignancies, like DLBCL. With this milestone achievement, TEPKINLY is now the second approved cancer treatment in the EU from our oncology portfolio, and AbbVie's third blood cancer medicine across the world.'
Under the oncology collaboration, the companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.
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