- AbbVie’s Epkinly (epcoritamab) has received Health Canada approval in combination with lenalidomide and rituximab for adults with relapsed or refractory Grade 1, 2, or 3a follicular lymphoma after at least one prior systemic therapy.
- The approval is supported by the Phase 3 EPCORE FL-1 study of 488 patients, in which Epkinly plus lenalidomide and rituximab reduced the risk of disease progression or death by 79% versus lenalidomide and rituximab alone (HR 0.21).
- Follicular lymphoma accounts for approximately 20%–25% of NHL diagnoses in Canada, with around 2,400–3,000 new cases annually. The disease commonly relapses and is generally considered incurable.
- The new indication expands Epkinly’s role in relapsed/refractory FL, providing an additional treatment option for patients who have already received systemic therapy.
Takeaways:
The Canadian approval expands Epkinly into a second major lymphoma indication (after DLBCL), giving AbbVie a bispecific‑based triplet option in relapsed/refractory follicular lymphoma (FL) where ~2,400–3,000 new cases arise annually in Canada and many patients eventually relapse on lenalidomide–rituximab. Commercially, this supports mid‑term oncology growth for Epkinly (already approaching ~$300M in annual sales) and positions the drug against competing bispecifics (e.g., mosunetuzumab) and CAR‑T in an FL market projected to grow ~7–8% CAGR, while reinforcing AbbVie’s shift toward fixed‑duration, chemo‑sparing immuno‑oncology regimens.
Source: CA Newswire
