FDA Grants Full Approval To AbbVie’s EPKINLY + R2 For Relapsed Or Refractory Follicular Lymphoma

AbbVie announced that the U.S. FDA has approved EPKINLY® (epcoritamab-bysp), a subcutaneously administered T-cell–engaging bispecific antibody, in combination with rituximab and lenalidomide (R2) for adults with relapsed or refractory follicular lymphoma (FL). The approval is supported by pivotal Phase 3 EPCORE® FL-1 data, which showed that fixed-duration EPKINLY + R2 delivered significant clinical benefits compared to standard R2 therapy. AbbVie noted that this combination may shift the current treatment paradigm by offering earlier, more effective intervention for FL patients.

"Today's milestone marks meaningful progress for people living with follicular lymphoma. With a bispecific-based therapy that can be administered in a variety of medical settings, patients have the possibility of accessing this treatment at sites of care closer to where they live," said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.

Follicular lymphoma, a slow-growing type of non-Hodgkin lymphoma, affects roughly 15,000 people annually in the United States and remains incurable with existing options. Patients frequently experience relapse, and in some cases, the disease can progress to the more aggressive diffuse large B-cell lymphoma (DLBCL). In the EPCORE FL-1 study, EPKINLY + R2 demonstrated a 79% reduction in the risk of disease progression or death and achieved an overall response rate of 89%, including a 74% complete response rate—significantly higher than outcomes seen with R2 alone.

"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," said Daejin Abidoye, MD, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie.

Safety outcomes for the combination were consistent with the known profiles of epcoritamab and R2, with common adverse events including rash, respiratory infections, fatigue, injection-site reactions, gastrointestinal effects, and cytokine release syndrome (CRS). CRS occurred in 24% of patients, mostly low grade, and only one case of Grade 1 ICANS was reported. The regimen carries a Boxed Warning for CRS and ICANS. EPKINLY + R2 previously received Breakthrough Therapy Designation, and with the confirmatory Phase 3 data, the FDA has now converted EPKINLY’s earlier accelerated monotherapy approval to a full approval. AbbVie and partners plan to seek additional global regulatory clearances.

"Recurrent follicular lymphoma can be an incurable, complex and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey," said Lorenzo Falchi, M.D., lymphoma specialist, department of medicine, Memorial Sloan Kettering Cancer Center. "The results shown with EPKINLY + R2 in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with R2 alone. These data, delivered by a regimen that's chemotherapy-free and can be administered in the outpatient setting, suggest that EPKINLY + R2 could potentially become a new standard of care."