Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The target action date for the FDA decision is March 31, 2024. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

The BLA was supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2). Results from these studies investigating odronextamab in both FL and DLBCL were last presented at the 64th American Society of Hematology Annual Meeting.

The FDA previously granted odronextamab Orphan Drug Designation and Fast Track Designation for FL and DLBCL. In August, the European Medicines Agency accepted for review a Marketing Authorization Application for odronextamab for the treatment of adult patients with R/R FL or R/R DLBCL who have progressed after at least two prior systemic therapies.

FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, and although many patients are responsive to initial treatment, approximately 20% are expected to relapse within two years and have shorter remissions with each successive line of therapy. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). As these blood cancers progress, they become increasingly hard to treat, especially in the third-line setting and beyond, leaving patients with few treatment options.

Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.