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AbbVie have provided updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL).
The FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp (EPKINLY) for the treatment of adult patients with R/R FL after two or more therapies. Additionally, the EMA has validated a Type II application for epcoritamab (TEPKINLY) for the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.
"The FDA granted BTD and validated European application are an important step in our commitment to improving the lives of patients with relapsed/refractory follicular lymphoma, a complex blood cancer with limited treatment options," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "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."
These updates were supported by previously announced results from the Phase 1/2 EPCORE NHL-1 clinical trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including FL. Data from the FL cohort of the trial, including an optimized dosing schedule allowing for outpatient administration, will be presented at the upcoming Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023.
BTD may expedite the development and review of investigational medicines by the FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies. EMA validation confirms that the submitted regulatory application is complete and initiates the scientific review process by the EMA's Committee for Medicinal Products for Human Use (CHMP).
FL is typically an indolent, or slow-growing, form of NHL that arises from B-cell lymphocytes. It is the second most common form of NHL overall, accounting for 20 percent to 30 percent of all NHL cases globally. Although FL is an indolent lymphoma, it is considered incurable with current standard of care therapies.
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 commercialisation.