Epcoritamab receives positive CHMP opinion for the treatment of adult patients with R/R FL

On June 28, 2024, it was announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion to epcoritamab, a bispecific T-cell engaging antibody, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), who have received ≥2 lines of systemic therapy. This announcement is based on key results from the phase II/III EPCORE NHL-1 trial (NCT03625037).¹

EPCORE NHL-1 trial: N=127, median follow-up was 14.8 months, overall response rate was 82%, complete response rate was 60%, including 67% of patients achieved minimal residual disease (MRD) negativity.² The most common (≥10%) adverse reactions were cytokine release syndrome (CRS), injection site reactions, pyrexia, neutropenia, anemia, thrombocytopenia, diarrhea, nausea, headache, upper respiratory tract infection, pneumonia, and rash.¹

If approved, epcoritamab would become the first and only bispecific antibody conditionally approved as a monotherapy in the European Union to treat both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL), who have received ≥2 lines of systemic therapy.¹

U.S. Food & Drug Administration (FDA)

On June 27, 2024, epcoritamab received accelerated U.S. FDA approval for the treatment of adults patients with R/R FL, who have received ≥2 lines of systemic therapy.

Japan European Commission and the Ministry of Health, Labour and Welfare

In September 2023, epcoritimab received approval from both the European Commission and the Ministry of Health, Labour and Welfare of Japan for patients with R/R DLBCL, high-grade-B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B, who have received ≥2 lines of systemic therapy.