Odronextamab BLA Resubmission for Relapsed or Refractory Follicular Lymphoma Accepted by FDA

Regeneron Pharmaceuticals resubmitted a Biologics License Application (BLA) for odronextamab in relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy. In a press release, the company announced the FDA has accepted the resubmission.

In the complete response letter for the prior BLA submitted by Regeneron, the FDA identified an enrollment target that had not been met for the OLYMPIA-1 phase 3 confirmatory trial, in which odronextamab monotherapy is compared with rituximab plus standard-of-care chemotherapies for FL. The new submission has met this target and received FDA approval.

Odronextamab is a CD20 x CD3 bispecific antibody developed by Regeneron using its proprietary humanized mouse immune system genetically engineered platform. Marketed under the brand name Ordspono, this agent has approval in the European Union for relapsed or refractory FL or diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic therapy.

Regeneron’s resubmitted BLA was bolstered by data from the open-label phase 1 ELM-1 and phase 2 ELM-2 clinical trials, both of which are ongoing. Patients enrolled in these trials had an overall response rate of 80%, and 74% achieved complete response. Sixty-seven percent of patients experienced serious adverse events, where events with an incidence of 10% or greater included COVID-19 infection, cytokine release syndrome, and pneumonia.

The FDA set an action date of July 30, 2025, for its decision on the BLA resubmission. Regeneron is continuing clinical investigations of monotherapy and polytherapy use of odronextamab for B-cell non-Hodgkin lymphoma (B-NHL). The OLYMPIA-2 phase 3 trial compares odronextamab plus chemotherapy with rituximab plus standard-of-care chemotherapy for FL. The ELM-2 trial evaluates odronextamab use in FL and DLBCL, mantle cell lymphoma, marginal zone lymphoma, and other B-NHL subtypes.

Reference

Odronextamab BLA accepted for FDA review for the treatment of relapsed/refractory follicular lymphoma. Press release. Regeneron Pharmaceuticals, Inc. February 26, 2025. Accessed February 26, 2025. https://investor.regeneron.com/news-releases/news-release-details/odronextamab-bla-accepted-fda-review-treatment