Regeneron Pharmaceuticals announced that the FDA has accepted the resubmitted Biologics License Application (BLA) for odronextamab, a treatment for relapsed/refractory follicular lymphoma (FL) in patients who have undergone at least two prior systemic therapies. The FDA is expected to make a decision by July 30, 2025.

The acceptance follows the completion of an FDA-mandated enrollment target for the Phase 3 confirmatory trial (OLYMPIA-1). The resubmission is backed by data from Phase 1 and pivotal Phase 2 trials, which showed an 80% overall response rate and a 74% complete response rate. Serious adverse events were reported in 67% of patients, with cytokine release syndrome, COVID-19, and pneumonia being the most common.

Odronextamab is already approved in the European Union under the name Ordspono for treating FL and diffuse large B-cell lymphoma (DLBCL). The drug is being further investigated in multiple trials, including as a monotherapy in Phase 3 trials against standard chemotherapy treatments.

Regeneron continues to expand its hematology portfolio, leveraging its proprietary VelociSuite technology for developing bispecific antibodies and other novel therapies. The company remains committed to advancing innovative treatments for blood cancers and rare blood disorders.