Health Canada Approves EPKINLY (Epcoritamab) Combination for Relapsed Follicular Lymphoma

Health Canada has approved EPKINLY (epcoritamab) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory Grade 1, 2 or 3a follicular lymphoma who have received at least one prior line of systemic therapy. AbbVie and Genmab, which co-develop the drug, announced the approval on September 24, 2026. Follicular lymphoma accounts for roughly 20-25% of non-Hodgkin lymphoma diagnoses in Canada, with an estimated 2,400 to 3,000 Canadians diagnosed annually; the disease typically follows a slow-growing but incurable course, with most patients eventually relapsing and needing further treatment. The approval is most directly relevant to hospital and cancer-centre pharmacy teams involved in preparing and monitoring lymphoma regimens, rather than community pharmacy practice.

The approval is supported by the Phase 3 EPCORE FL-1 trial, which randomized 488 adults with relapsed or refractory follicular lymphoma to epcoritamab plus rituximab and lenalidomide (R2) or R2 alone. The epcoritamab combination reduced the risk of disease progression or death by 79% compared with R2 alone (hazard ratio 0.21). Overall response rate was 95% with the epcoritamab combination versus 79% with R2 alone, and complete response rate was 83% versus 50% at a median follow-up of 14.8 months; median progression-free survival was not yet reached in the epcoritamab arm versus 11.7 months with R2 alone. The trial results were published in The Lancet and presented at the American Society of Hematology.

"Despite advances in care, follicular lymphoma remains incurable," said Dr. Laurie Sehn, Clinical Professor of Medicine in the Division of Medical Oncology at BC Cancer and the University of British Columbia, in AbbVie's announcement. "While many patients have prolonged benefit after initial therapy, most will experience lymphoma recurrence and require further treatment." Gurjot Basra, Manager of Patient Programs, Research & Advocacy at Lymphoma Canada, said "because follicular lymphoma can return over time, continued progress matters to people living with the disease and to the families who support them."

Practice guidance for pharmacists

• Epcoritamab is a CD3xCD20 bispecific antibody administered subcutaneously on a step-up dosing schedule specifically to reduce the incidence and severity of cytokine release syndrome (CRS); confirm your institution's CRS monitoring and management protocol covers this new indication's dosing schedule, not just the drug's existing use.
• Most CRS events occur during the first treatment cycle, particularly around the first full step-up dose -- ensure staff and patients know the signs of CRS (fever, hypotension, hypoxia) and when to seek urgent care, especially in the days immediately following early doses.
• This is a combination regimen with lenalidomide (an oral immunomodulatory agent with its own REMS-type controlled-distribution requirements in some jurisdictions) and rituximab -- verify all three components are coordinated on the same treatment calendar, since staggered or missed doses of any one agent could affect the regimen's efficacy.
• Given the drug is newly indicated for an earlier line of therapy (after just one prior treatment, rather than later-line use), review whether your cancer centre's order sets and pathways have been updated to reflect the new indication and reimbursement status.

The approval adds a new option earlier in the relapsed or refractory follicular lymphoma treatment pathway, at a point when the disease has historically been managed with lenalidomide and rituximab alone. Coverage and funding decisions by public and private drug plans will determine how quickly the combination reaches patients outside of clinical trials.