Regeneron Secures EU Approval for Lymphoma Treatment Ordspono Following FDA Rejection

EU Approval:
The European Commission has granted conditional approval to Regeneron's bispecific antibody odronextamab (Ordspono) for treating relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

First Bispecific Approval:
This marks Regeneron's first bispecific antibody approval globally, providing an off-the-shelf treatment option for lymphoma patients.

Clinical Trial Results:
Phase 2 clinical trials showed that Ordspono led to partial or complete responses in 80% of patients with follicular lymphoma and about half of those with diffuse large B-cell lymphoma.

FDA Rejection:
The FDA rejected Ordspono due to concerns over the enrollment status in confirmatory studies, not due to issues with its approvability.

Market Potential:
Analysts predict that Ordspono could become a significant revenue contributor, with forecasted annual sales of $800 million by 2035, primarily from treating follicular lymphoma.