Regeneron Narrows Focus for Odronextamab Approval, Prioritizes Follicular Lymphoma

Regeneron Pharmaceuticals has announced a strategic shift in its regulatory approach for odronextamab, its investigational bispecific T-cell engager antibody. The company has decided to focus its accelerated approval efforts solely on follicular lymphoma (FL), while abandoning plans for a similar pathway in diffuse large B cell lymphoma (DLBCL).

FDA Grants Priority Review for Follicular Lymphoma Application

In a significant development, Regeneron revealed that the U.S. Food and Drug Administration (FDA) has granted priority review to the biologics license application (BLA) for odronextamab in relapsed or refractory follicular lymphoma. This decision sets the stage for a potential approval by July 30, 2025, marking a crucial milestone in the drug's journey to market.

The BLA submission is supported by data from the pivotal Phase II ELM-2 study, which demonstrated impressive efficacy results. The trial reported an 80% objective response rate and a 73% complete response rate in patients treated with odronextamab, underscoring the drug's potential in addressing the unmet needs of FL patients.

Strategic Realignment for DLBCL Indication

Regeneron has decided to withdraw its pursuit of accelerated approval for odronextamab in relapsed or refractory diffuse large B cell lymphoma. This decision comes in light of what the company describes as "competitor developments" in the DLBCL space. While specific details were not provided, recent announcements from competitors such as Roche and Genmab may have influenced Regeneron's strategy.

A company spokesperson stated, "Due to competitor developments, we no longer believe odronextamab in R/R DLBCL has an accelerated approval path and therefore, we plan to seek full approval pending data from ongoing Phase III studies."

This shift in focus allows Regeneron to concentrate its resources on the follicular lymphoma indication, where the company believes odronextamab has a "potentially best-in-class" profile. The drug's mechanism of action, which involves binding to both CD20 and CD3 surface proteins, positions it as a promising option for early-stage lymphoma patients, with the potential for use with or without chemotherapy.