European Commission Approves Odronextamab for Follicular Lymphoma, DLBCL

The European Commission (EC) has approved odronextamab (Ordspono) for the treatment of relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, according to a press release from Regeneron, the manufacturer of the drug.

The approval is based on results from the phase I ELM-1 and phase II ELM-2 trials published in Annals of Oncology. Patients with FL achieved an objective response rate (ORR) of 80% and a complete response (CR) rate of 73%. Among patients with DLBCL who had not received prior chimeric antigen receptor (CAR) T-cell therapy, 52% achieved an ORR and 31% achieved a CR. Among patients with DLBCL who progressed after CAR-T therapy, 48% achieved an ORR and 32% achieved a CR.

The most common adverse events included cytokine release syndrome (54%), neutropenia (41%), pyrexia (39%), anemia (38%), thrombocytopenia (27%), diarrhea (24%), and COVID-19 (22%).

“The EC approval of [odronextamab] is a meaningful advancement for [European Union] patients and their physicians as a new option to treat both indolent and aggressive lymphomas,” trial investigator Stefano Luminari, MD, Professor of Oncology at the University of Modena and Reggio Emilia, said in the press release. “Physicians, especially in the community setting, will have an off-the-shelf option that can be administered out-patient, offering the chance for complete remission.”

Read more: Odronextamab Has ‘Meaningful Clinical Efficacy’ in DLBCL