Conditional Marketing Authorization Recommended for Epcoritamab in Relapsed, Refractory DLBCL

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional Marketing Authorization for epcoritamab (TEPKINLY) monotherapy in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

The application for the approval of epcoritamab, a subcutaneous bispecific antibody, is based on results from the phase I/II EPCORE NHL-1 trial, which was conducted by Catherine Thieblemont, MD, PhD, of the Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris, and colleagues.

The open-label, multicenter trial evaluated the preliminary efficacy and safety of epcoritamab in patients with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkinlymphoma, including DLBCL. The overall response rate, which was the primary endpoint of the study, was 63.1% in the study. Cytokine release syndrome was the most common treatment-emergent adverse event.

The final European Commission decision on this indication for epcoritamab is expected later this year, according to a news release from AbbVie, the manufacturer of the drug.

“Subcutaneous epcoritamab could become a promising treatment option for the DLBCL community, and I look forward to the European Commission’s final decision,” Dr. Thieblemont said in the release.

Source: AbbVie, July 2023