The European Commission has approved Regeneron’s odronextamab, branded Ordspono, for the treatment of adults with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
This is the first global regulatory approval for the drug, a bispecific antibody designed to link T-cells to lymphoma cells. The approval is based on phase 1 and phase 2 clinical trials that showed significant response rates.
In follicular lymphoma, the trials demonstrated an objective response rate (ORR) of 80%, with 73% achieving a complete response. In diffuse large B-cell lymphoma, the ORR was 52% in patients who had not received CAR-T therapy, and 48% in those who had progressed after CAR-T therapy.
Ordspono is an off-the-shelf treatment that can be administered in an outpatient setting. Regeneron is continuing to investigate the drug in ongoing clinical trials, including studies focused on its use in earlier lines of therapy and in combination with other treatments.
