UAE is the first country after the country of origin (US) to be granted conditional regulatory approval.
TEPKINLY™ (epcoritamab) has received conditional regulatory approval in the United Arab Emirates (UAE) on August 15th 2023, being the first country after the country of origin (United States) to grant conditional regulatory approval. This milestone marks a significant step forward in the field of oncology and offers new hope for patients. TEPKINLY™ (epcoritamab) is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
TEPKINLY™ (epcoritamab) is the First and Only Subcutaneous Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL).6
AbbVie submitted TEPKINLY eCTD complete file through UAE MOHAP fast track review pathway. The approval by the UAE regulatory authorities underscores the potential of epcoritamab to provide a transformative treatment option for non-Hodgkins lymphoma patients. UAE followed a rigorous review process, during which the safety and efficacy data of epcoritamab were thoroughly assessed. The successful outcome of this process underscores the robustness of the drug’s clinical trial data which have demonstrated its efficacy and safety profile and its potential to address an unmet medical need, offering renewed optimism to patients and their families.
“We are delighted by the approval of epcoritamab in the UAE, which signifies a breakthrough in non-Hodgkins lymphoma treatment,” said Hassan Sabah, General Manager Gulf and LEVANT at AbbVie Biopharmaceuticals. “This achievement is a testament to the keenness of the authorities in UAE to accelerate patients access to innovation, as well as to years of dedicated research and development in AbbVie to improving patient outcomes.”
Medical part:
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 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
About Epcoritamab:
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody® technology. Genmab’s DuoBody®-CD3 technology is designed to direct cytotoxic T-cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.3 CD20 is expressed on B-cells and is a clinically validated therapeutic target in many B-cell malignancies, including DLBCL, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.4,5
The safety and efficacy of epcoritamab remain under evaluation in the European Union (EU). The U.S. Food and Drug Administration (FDA) recently approved epcoritamab under the brand name EPKINLY™ (epcoritamab-bysp) in the United States, and it is indicated for the treatment of adult patients with R/R DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. Epcoritamab-bysp is approved under the FDA’s Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
About AbbVie in Oncology:
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.
About AbbVie:
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 – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
