AbbVie has received full approval in its US homeland for its CD3×CD20 bispecific antibody (BsAb) epcoritamab combined with lenalidomide and rituximab in relapsed or refractory follicular lymphoma (r/r FL). The decision is based on the Phase III EPCORE FL-1 trial showing 79% reduction in disease progression or death risk versus a control group. The chemotherapy-free regimen achieved 89% overall response rate, with 74% complete response rate (CRR) and median progression free survival (mPFS) not reached versus 11.2 months for standard therapy in 488 patients. The subcutaneous administration offers outpatient treatment convenience, supporting a potential new standard of care in indolent lymphoma, with the safety profile consistent with that of individual agents.

The approval represents the third indication in the US market, following accelerated approvals in the diffuse large B cell lymphoma (DLBCL) and FL monotherapy settings, with global expansion including the European Union and Japan. Epcoritamab generated USD 190-million sales in the first nine months of 2025, representing 78.7% year-on-year growth and becoming a core growth driver in AbbVie's haematology portfolio. China's National Medical Products Administration (NMPA) granted the BsAb priority review in August 2025 for FL combination therapy, with four submissions under review.

According to PharmCube's NextBiopharm® database, epcoritamab is one of four CD3×CD20 BsAbs approved globally, the other three belonging to Roche and Regeneron. Click here to request a free trial for NextBiopharm®.