AbbVie’s oncology drug epcoritamab receives conditional regulatory approval in the UAE

UAE – AbbVie’s TEPKINLY (epcoritamab) has been given conditional regulatory approval by the Ministry of Health and Prevention (MoHAP) to treat aggressive types of Diffuse Large B-Cell Lymphoma (DLBCL).

TEPKINLY (epcoritamab) is indicated for the treatment of adult patients with relapsed or refractory Diffuse Large B-cell Lymphoma after two or more lines of systemic therapy.

It is the first and only subcutaneous bispecific antibody to treat adult patients with relapsed or refractory Diffuse Large B-Cell Lymphoma.

In a press release, Hassan Sabah, General Manager of the Gulf & Levant Division at AbbVie Biopharmaceuticals, said: “We are delighted by the approval of epcoritamab in the UAE, which signifies a breakthrough in non-Hodgkins lymphoma treatment.”

Prior to the conditional regulatory approval from the Ministry of Health and Prevention, AbbVie submitted the TEPKINLY eCTD complete file through the UAE MOHAP fast-track review pathway.

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.

This pivotal EPCORE clinical trial aimed at 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.

DLBCL is an aggressive type of cancer that develops in the lymphatic system and it is the most common type of B-cell NHL worldwide, accounting for approximately 30 percent of all global cases.

AbbVie’s breakthrough oncology drug epcoritamab has now gained conditional regulatory approval in the United Arab Emirates.

Consequently, the approval by the UAE regulatory authorities underscores the potential of epcoritamab to provide a transformative treatment option for non-Hodgkins Lymphoma patients.

This regulatory milestone marks a significant step forward in the field of oncology and offers new hope for patients with aggressive types of Diffuse Large B-cell Lymphoma.

Notably, the MoHAP registration of epcoritamab is the first regulatory approval outside the United States Food and Drug Administration (US FDA).

This approval underlines AbbVie’s commitment to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types.

“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,” stated Hassan Sabah.

It is worth noting that 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.

With the conditional regulatory approval from the MoHAP, AbbVie is set to launch epcoritamab in the United Arab Emirates.

The successful outcome of this process underscores the robustness of the drug’s clinical trial data which have demonstrated its efficacy and safety profile.

Clinical data to date suggest that epcoritamab has the potential to not only address an unmet medical need but also to extend patients’ lives in early-stage disease.

The MoHAP approval is especially significant for patients with relapsed or refractory diffuse Large B-Cell Lymphoma, offering a new wave of renewed optimism to both patients and their families.

For this reason, DLBCL patients in the United Arab Emirates may be the first to receive the treatment outside the United States.

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