Health Canada approved AbbVie’s EPKINLY (epcoritamab) for a new indication in treating follicular lymphoma (FL).
The approval covers adult patients with relapsed or refractory FL who have received at least one prior systemic therapy. Physicians will administer EPKINLY in combination with lenalidomide and rituximab.
Positive results from the Phase 3 EPCORE FL-1 study supported the authorization. The trial demonstrated that adding EPKINLY significantly reduced the risk of disease progression or death compared to the standard combination of lenalidomide and rituximab alone.
This regulatory milestone provides a new treatment option for Canadian patients living with this recurring form of blood cancer.