The US Food and Drug Administration (FDA) has approved AbbVie’s Epkinly (epcoritamab-bysp) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The approval is for the use of the T-cell engaging bispecific antibody, Epkinly, administered subcutaneously, in combination with rituximab and lenalidomide (Epkinly + R²).
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It is supported by data from the Phase III Epcore FL-1 study, which assessed the fixed-duration of the combination therapy against the standard treatment of R².
The findings highlight the potential to transform treatment strategies for FL, a slow-growing form of non-Hodgkin lymphoma (NHL) arising from B-lymphocytes, affecting 15,000 new patients annually in the US.
The Epcore FL-1 trial enrolled a broad patient population, showing that Epkinly in combination with R2 lowered the risk of disease progression or mortality by 79% comparison to R2 alone.
The overall response rate was 89% for Epkinly + R2 versus 74% for R2. Median progression-free survival was not reached in the Epkinly group versus 11.2 months for R2. Complete responses were achieved in 74% of patients receiving Epkinly + R2 compared to 43% with R2.
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By GlobalDataAbbVie oncology, solid tumour and haematology therapeutic area head and vice-president Daejin Abidoye stated: “With this approval, Epkinly is now the first bispecific antibody available for patients with follicular lymphoma in the second-line plus setting. New options are needed to improve outcomes for patients with relapsed or refractory disease.”
Epkinly as a single agent received accelerated approval from the FDA in June 2024 to treat R/R FL after two or more lines of systemic therapy.
Additional international regulatory submissions are scheduled.
In October 2025, the FDA approved AbbVie’s supplemental new drug application, updating the indication statement for Rinvoq (upadacitinib) to treat inflammatory bowel disease.
