AbbVie, Genmab Issue Positive FDA, EMA Updates For Epcoritamab To Treat R/R Follicular Lymphoma

(RTTNews) - Drug makers AbbVie (ABBV) and Genmab (GMAB) announced Monday positive updates from the U.S. Food and Drug Administration or FDA and European Medicines Agency or EMA for epcoritamab (Epkinly / Tepkinly) for relapsed or refractory (R/R) follicular lymphoma (FL).

Epcoritamab, co-developed by AbbVie and Genmab, is an investigational T-cell engaging bispecific antibody administered subcutaneously for R/R FL, a complex blood cancer with limited treatment options. Epcoritamab is approved under the brand name EPKINLY in the United States and TEPKINLY in the European Union.

The FDA has granted Breakthrough Therapy Designation or BTD to epcoritamab-bysp (EPKINLY) for the treatment of adult patients with R/R FL after two or more therapies.

In addition, the EMA has validated a Type II application for epcoritamab (TEPKINLY) for the same indication. If approved, R/R FL would be the second conditionally approved indication for epcoritamab in the European Union.

The company noted that its U.S. And Europe updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab.

The companies will present data from the FL cohort of the trial, including an optimized dosing schedule allowing for outpatient administration, at the upcoming Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023.

As per the oncology collaboration deal between AbbVie and Genmab, the companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Mariana Cota Stirner, vice president, therapeutic area head for hematology, AbbVie, said, "Together with Genmab, we are continuing to investigate epcoritamab as a potential core therapy for multiple B-cell malignancies, including diffuse large B-cell lymphoma and now follicular lymphoma."

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies.

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