EPKINLY® receives Health Canada Approval for Adults with Follicular Lymphoma

• Follicular lymphoma (FL) is the second most common subtype of non-Hodgkin lymphoma (NHL), accounting for approximately 20% to 25% of NHL diagnoses in Canada. Approximately 2,400 to 3,000 Canadians are diagnosed with FL each year. Follicular lymphoma is difficult to treat and often returns.^1,2
• Although treatment can control the disease, follicular lymphoma is generally considered incurable, with patients typically experiencing repeated relapses and progressively shorter remissions over time.³
• In a Phase 3 study, EPKINLY® in combination with rituximab and lenalidomide reduced the risk of disease progression or death by 79% compared with rituximab and lenalidomide alone.^4,5

MONTREAL, Sept. 24, 2026 /CNW/ -- AbbVie (NYSE: ABBV) announced today that Health Canada has issued a Notice of Compliance for EPKINLY^® (epcoritamab) with a new follicular lymphoma (FL) indication. EPKINLY^®, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory Grade 1, 2, or 3a FL who have received at least one prior line of systemic therapy.⁶

Follicular lymphoma (FL) is a typically slow-growing form of blood cancer that can follow a prolonged disease course. While many patients respond well to initial treatment, additional therapy is often needed over time as the disease progresses or returns. As a result, patients may receive multiple lines of treatment throughout their journey, highlighting the importance of having effective treatment options available at different stages of care.³

"Despite advances in care, follicular lymphoma remains incurable. While many patients have prolonged benefit after initial therapy, most will experience lymphoma recurrence and require further treatment" said Dr. Laurie Sehn, Clinical Professor of Medicine, Division of Medical Oncology, British Columbia Cancer and the University of British Columbia. "The positive results from EPCORE FL-1 show that adding epcoritamab to lenalidomide and rituximab significantly reduces the risk of lymphoma progression or death. Having a novel and more effective treatment option after prior therapy is important for patients living with this recurring disease."

The authorization is supported by results from the Phase 3 EPCORE FL-1 study, which included 488 adults with relapsed or refractory follicular lymphoma who had received at least one prior line of systemic therapy. In the study, adding EPKINLY^® to lenalidomide and rituximab reduced the risk of disease progression or death by 79% compared with lenalidomide and rituximab alone (HR 0.21; 95% CI: 0.13–0.33; p<0.0001).^4,5

"For people living with follicular lymphoma, a relapse can mean facing the uncertainty of cancer treatment all over again – including new decisions about what comes next and how treatment will fit into their lives," said Gurjot Basra, Manager of Patient Programs, Research & Advocacy, Lymphoma Canada. "Because follicular lymphoma can return over time, continued progress matters to people living with the disease and to the families who support them."

EPKINLY^® is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

"For many people living with follicular lymphoma, a relapse is more than a medical setback, it can feel like having the future they had begun to rebuild suddenly placed in doubt," said Tanu Misra, Vice President and General Manager, AbbVie Canada. "It can mean returning to appointments, tests, and difficult treatment decisions, while families and loved ones once again face the uncertainty that comes with a cancer diagnosis. Every advance that helps delay disease progression represents something deeply meaningful: more time for patients to focus on living their lives, creating memories with those they love, and looking ahead with greater hope. This milestone reinforces our commitment to helping bring meaningful innovations to Canadians affected by blood cancer." 

About EPKINLY^®
EPKINLY^® is a type of medicine called a bispecific antibody. It is designed to connect two different types of cells: T cells, which are part of the immune system, and B cells, including the abnormal B cells involved in follicular lymphoma. By bringing these cells together, EPKINLY^® is designed to help the immune system target the B cells. EPKINLY^® is administered by injection under the skin. AbbVie and Genmab continue to study epcoritamab, alone and in combination with other treatments, across a range of blood cancers. Please consult the current Canadian EPKINLY ^® Product Monograph at Abbvie.ca for complete indication, dosing and safety information.⁶

About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across blood cancers and solid tumors, with a focus on targeted medicines and treatment modalities including small molecules, antibody-drug conjugates, immuno-oncology-based therapeutics, multispecific antibodies and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our oncology portfolio includes approved and investigational treatments for a wide range of blood and solid tumors, and we are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  www.abbvie.ca. Follow AbbVie in Canada on LinkedIn, Instagram, and YouTube. 

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¹ Canadian Cancer Society. Non-Hodgkin lymphoma statistics. Available at: cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed September 2026

² Kuruvilla J, Assouline S, Hodgson D, et al. A Canadian evidence-based guideline for the first-line treatment of follicular lymphoma: Joint consensus of the Lymphoma Canada Scientific Advisory Board. Clinical Lymphoma, Myeloma & Leukemia. 2015;15(2):59–74.

³ Keating MM. Follicular Non-Hodgkin Lymphoma: First Relapse and Beyond. Canadian Hematology Today. 2024.

⁴ Falchi L, Nijland M, Huang H, et al. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. The Lancet. 2026;407(10524):161–173. doi:10.1016/S0140-6736(25)02360-8.

⁵ ClinicalTrials.gov. Study of Subcutaneous Epcoritamab in Combination with Intravenous Rituximab and Oral Lenalidomide in Adult Participants with Follicular Lymphoma (EPCORE FL-1), NCT05409066.

⁶ AbbVie. EPKINLY^® (epcoritamab injection/epcoritamab for injection) Product Monograph. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/EPKINLY_PM_EN.pdf

SOURCE AbbVie Canada

Media Inquiries: Hind Mahreche, AbbVie, 514-348-8175, [email protected]