Odronextamab: Investigational Treatment for Lymphoma Awaits FDA Approval

Odronextamab is an investigational CD20xCD3 bispecific antibody being developed by Regeneron Pharmaceuticals, Inc. for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), both subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is characterized as a slow-growing subtype, whereas DLBCL is more aggressive.

The drug is designed to bridge CD20 on cancer cells with CD3-expressing T cells, facilitating local T-cell activation and cancer-cell killing. A Biologics License Application (BLA) has been submitted to the FDA for odronextamab to treat adult patients with R/R FL or R/R DLBCL who have progressed after at least two prior systemic therapies. The target action date for the FDA decision was March 31, 2024, but the agency issued Complete Response Letters (CRLs) related to the enrollment status of the confirmatory trials. Importantly, the CRLs did not identify any approvability issues with odronextamab's clinical efficacy, safety, trial design, labeling, or manufacturing.

The FDA has granted odronextamab Orphan Drug Designation and Fast Track Designation for FL and DLBCL. Regeneron is also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other B-NHLs.

This development highlights the ongoing efforts to provide new treatment options for patients with challenging forms of lymphoma, emphasizing the importance of continued research and regulatory review in advancing cancer therapy.