#United States #AbbVie #North Chicago #Lymphoma #EPKINLY

AbbVie Secures FDA Approval for EPKINLY

AbbVie has made significant strides in oncology with its recent announcement regarding the U.S. FDA approval of EPKINLY® (epcoritamab-bysp). This innovative therapy, administered subcutaneously, is designed for adult patients battling relapsed or refractory (R/R) follicular lymphoma (FL), in conjunction with rituximab and lenalidomide — collectively referred to as EPKINLY + R2. This marks a crucial advancement, as EPKINLY + R2 becomes the first and only bispecific antibody combination therapy available for FL treatment following at least one line of systemic therapy.

Efficacy of EPKINLY + R2

The approval is grounded in compelling data from the Phase 3 clinical trial known as EPCORE® FL-1. In this pivotal study, EPKINLY + R2 was shown to outperform the standard care regimen (R2 alone), showcasing a significant reduction in disease progression and offering a large Population of FL patients a new glimmer of hope. According to the trial results, approximately 89% of patients treated with EPKINLY + R2 responded positively, achieving a remarkable complete response rate of 74%.

Dr. Lorenzo Falchi, a lymphoma specialist at the Memorial Sloan Kettering Cancer Center, emphasizes the necessity of such advancements, stating that recurrent follicular lymphoma often presents a complicated and persistent challenge in cancer treatment. With EPKINLY + R2, patients may experience durable outcomes, moving treatment into a chemotherapy-free paradigm that can be managed on an outpatient basis. This therapy has the potential to redefine clinical standards for how FL is managed, enabling earlier treatment interventions.

Addressing an Urgent Need

Follicular lymphoma, a typically indolent form of non-Hodgkin lymphoma arising from B-lymphocytes, affects around 15,000 new patients annually in the U.S. Despite existing therapies, the disease frequently relapses and can evolve into a more aggressive state known as diffuse large B-cell lymphoma (DLBCL). Thus far, treatment options have been limited, making the introduction of EPKINLY to the market particularly timely.

The EPCORE FL-1 study included a diverse array of participants, ensuring comprehensive data across different disease presentations, from indolent to more aggressive manifestations. The results are noteworthy: EPKINLY + R2 reduced the risk of progression or death by 79%, a statistic that underscores its revolutionary impact on patient care.

Risk and Safety Profile

As with any therapeutic intervention, understanding the safety profile is paramount. The side effects associated with EPKINLY + R2 were comparable to those observed in the individual agents in the regimen. Common adverse reactions—occurring in more than 20% of patients—comprised rash, upper respiratory infections, fatigue, and injection site reactions. Serious adverse events, including cytokine release syndrome (CRS), were monitored diligently throughout the trial, guiding the prescribing information which includes a boxed warning for serious side effects.

A Warm Reception from the Lymphoma Community

The FCA approval of EPKINLY signifies a pivotal moment for patients living with FL. Meghan Gutierrez, CEO of the Lymphoma Research Foundation, noted the meaningful progress this development represents for individuals affected by this condition, indicating that patients could potentially access EPKINLY in accessible care settings close to home.

Furthermore, EPKINLY + R2 has received Breakthrough Therapy Designation (BTD) from the FDA, underscoring its promise as a potentially transformative treatment. Abbvie aims to obtain additional international endorsements for EPKINLY and continues to explore its application across various hematologic malignancies with numerous ongoing trials.

As the oncology landscape rapidly evolves, AbbVie's commitment to fighting FL with groundbreaking therapies like EPKINLY stands to enhance the quality of life for many patients, pushing the boundaries of cancer care to new frontiers. The community eagerly anticipates future data presentations from the EPCORE FL-1 study, slated for the upcoming American Society of Hematology (ASH) meeting in December 2025. This privilege alone places EPKINLY + R2 at the forefront of revolutionizing treatment protocols for relapsed or refractory follicular lymphoma.