AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
AbbVie (NYSE: ABBV) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization for epcoritamab (TEPKINLY®) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The final European Commission decision on this indication for epcoritamab is anticipated later this year.
“As leaders in transforming standards of care, we strive to develop innovative medicines that can make an impact on patients facing aggressive blood cancers like DLBCL,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We are pleased with the recent CHMP positive opinion for epcoritamab, as it represents an important step in our journey to develop a potential core therapy for people living with B-cell malignancies, such as DLBCL.”
AbbVie’s application for the approval of epcoritamab is supported by results from the pivotal EPCORE™ NHL-1 Phase 1/2 open-label, multi-center trial evaluating the preliminary efficacy and safety of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including DLBCL. The primary endpoint of the study was overall response rate, as assessed by an independent review committee (63.1 percent).1 The most common treatment-emergent adverse event was cytokine release syndrome.1 Updated results were recently presented at multiple medical congresses.
“DLBCL is an aggressive and often treatment-resistant disease with limited therapeutic options for patients whose disease is refractory or who have experienced relapse after multiple lines of therapy,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “Subcutaneous epcoritamab could become a promising treatment option for the DLBCL community, and I look forward to the European Commission’s final decision.”
DLBCL is an aggressive type of cancer that develops in the lymphatic system.2 It is the most common type of B-cell NHL worldwide and accounts for approximately 30 percent of all global cases.2 Because NHL affects B-cell lymphocytes, the disease and its subtypes, including DLBCL, are classified as B-cell malignancies.2
Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.