FDA Approves EPKINLY to Treat Patients with Follicular Lymphoma in The Weekly Journal

FDA Approves EPKINLY® for Relapsed or Refractory Follicular Lymphoma

Introduction

AbbVie, one of the leading pharmaceutical companies, recently announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only bispecific antibody to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy. This news offers a glimmer of hope to patients who are in dire need of a new treatment option for this cancer type.

Understanding Follicular Lymphoma

Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and accounts for 20-30% of all NHL cases. It is considered incurable with current standard of care therapies and patients often relapse. Moreover, with each relapse, the remission period and time to next treatment get shorter. Furthermore, over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in over 25% of FL patients.

EPKINLY®: A New Treatment Option

EPKINLY® is the first and only T-cell engaging bispecific antibody approved in the U.S. for the treatment of R/R FL. It is designed to target both CD3 on T-cells and CD20 on B-cells, thereby bringing them together to kill cancer cells. According to the FDA, EPKINLY® is approved based on overall response rate (ORR) and durability of response under the FDA’s Accelerated Approval program. The approval is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Convenience and Potential

EPKINLY® treatment involves subcutaneous dosing, which is more convenient for patients, and can be given without mandatory hospitalization using a 3-step-up dosing regimen. The potential of this new therapy is huge for the treatment of multiple B-cell malignancies, and AbbVie considers it to be a core therapy in the fight against cancer. Epcoritamab, the active ingredient in EPKINLY®, was co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, while AbbVie will be responsible for further global commercialization.

Experts’ Views on EPKINLY®

Jeff Sharman, the Disease Chair for Hematology Research, Sarah Cannon Research Institute, believes that there is currently no clear standard of care treatment available for FL patients who face significant treatment challenges. He is of the opinion that the responses observed in the FL cohort of the EPCORE NHL-1 clinical trial as well as in patients with R/R DLBCL from the trial demonstrate the potential of EPKINLY® as an important treatment option for these patients. Lee Greenberger, the Chief Scientific Officer at The Leukemia & Lymphoma Society, opines that today’s approval is welcome news for those living with FL as it offers another tool in the physician’s arsenal for this difficult-to-treat form of cancer.

Conclusion

The approval of EPKINLY® by the FDA offers a new treatment option for patients with relapsed or refractory follicular lymphoma. The potential of this medication to serve as an important treatment option for FL and R/R DLBCL patients has been demonstrated in clinical trials. With this new treatment, patients and healthcare providers can now have more hope in the fight against this debilitating cancer.

Long-Tail Keywords

EPKINLY®
Epcoritamab-bysp
Relapsed or refractory follicular lymphoma
Bispecific antibody

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