▎WuXiEdited by Kant Content Team

Regeneron Pharmaceuticals, Inc. announced today,The U.S. FDA has accepted the resubmitted Biologics License Application (BLA) for the investigational therapy odronextamab, intended for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in patients who have received two or more lines of systemic therapy.The FDA is expected to complete the review by July 30, 2025.

This application is supported by data from Phase 1 clinical trial (ELM-1) and pivotal Phase 2 clinical trial (ELM-2).These data show,AcceptOdronextamab Achieves an Overall Response Rate of 80% (n=103) in Treated Patients, with 74% (n=95) Achieving Complete Response.

In terms of safety, 67% of patients experienced serious adverse events, with adverse events occurring at a rate ≥10% including cytokine release syndrome, COVID-19, and pneumonia.

Odronextamab is a bispecific antibody targeting CD20 and CD3, designed to connect CD20 on cancer cells with CD3-expressing T cells to promote localized T cell activation and cancer cell killing.It hasApproved in the EU(Product name: Ordspono) Used to treat patients with relapsed/refractory FL or diffuse large B-cell lymphoma (DLBCL) whose disease has progressed after two or more lines of systemic therapy. Regeneron has launched two Phase 3 clinical trials to evaluate the efficacy of odronextamab as a monotherapy or as part of a combination therapy for FL patients.

FL is one of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). Although FL grows slowly, the disease is incurable, and most patients will relapse after initial treatment. It is estimated that more than 120,000 patients worldwide are diagnosed with FL each year.

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