FDA Approves Epkinly in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma | iPharmaCenter

AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab) administered subcutaneously in combination with rituximab and lenalidomide (EPKINLY + R2) for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least one prior systemic therapy. This newly approved regimen is the first and only bispecific antibody combination therapy available for this patient population.

The approval was granted based on findings from the pivotal Phase 3 EPCORE FL-1 trial, which randomized 488 patients to receive EPkinly + R2 or the standard of care R2 alone. Patients had a median of one prior therapy, with some having two or more prior lines. The trial demonstrated that EPkinly + R2 significantly improved progression-free survival, reducing the risk of disease progression or death by 79% compared to R2 alone. Median progression-free survival was not reached in the EPkinly + R2 arm, compared to 11.2 months in the R2 arm.

Additionally, the overall response rate was 89% for patients receiving EPkinly + R2, with 74% achieving a complete response. This compares favorably to a 74% overall response and 43% complete response rate with R2 alone. Such results highlight the deep and durable efficacy of this chemotherapy-free, subcutaneously administered treatment that can potentially be delivered in outpatient settings.

Follicular lymphoma is a common, indolent form of non-Hodgkin lymphoma characterized by repeated relapses, with some cases progressing to more aggressive forms like diffuse large B-cell lymphoma. Current treatments are not curative, reflecting a significant unmet need for therapies that can provide long-lasting remissions earlier in the disease course.

EPKINLY + R2’s approval marks the third indication for Epkinly and is the first bispecific antibody combination therapy ever approved by the FDA for lymphoma. Previously, the FDA granted accelerated approval for Epkinly monotherapy in relapsed/refractory FL after two or more prior therapies, and this new indication converts that accelerated approval into full traditional approval in a combination setting, allowing its use earlier in treatment.

Leaders from oncology and lymphoma research emphasize that these results offer a potential new standard of care for patients with FL, improving disease control and quality of life by providing an effective, targeted immunotherapy option. This milestone also supports AbbVie’s position as a key player in advancing immuno-oncology therapeutics for hematologic cancers worldwide.

This FDA approval provides a promising new chemotherapy-free treatment for patients with relapsed or refractory follicular lymphoma, addressing a crucial need with a bispecific antibody combination that shows superior efficacy and durable responses compared to existing standard therapies.