Regeneron Shifts Strategy for Lymphoma Bispecific, Focuses on Follicular Lymphoma

Regeneron has adjusted its regulatory approach for odronextamab, opting to pursue accelerated approval only in relapsed or refractory follicular lymphoma (FL) while dropping plans for diffuse large B-cell lymphoma (DLBCL). The decision follows recent developments in the competitive landscape, the company revealed on Wednesday.
Priority Review for Follicular Lymphoma
The U.S. Food and Drug Administration (FDA) has granted priority review to Regeneron’s biologics license application for odronextamab in FL. The company expects a final decision by July 30, 2025. This marks a key milestone for the investigational bispecific T-cell engager, which binds to CD20 and CD3 surface proteins to facilitate T-cell-mediated destruction of CD20-expressing cancer cells.
Regeneron is currently evaluating odronextamab in multiple indications, including B-cell non-Hodgkin lymphoma, FL, and DLBCL. The company has positioned the drug as a “potentially best-in-class” treatment for FL, highlighting its ability to address early-stage lymphoma patients with or without chemotherapy.

Regulatory Setback and Competitive Challenges
In March 2024, the FDA declined to grant accelerated approval for odronextamab in both FL and DLBCL. At the time, Regeneron stated that the only concern raised by the agency was related to the enrollment status of its confirmatory studies, not the drug’s safety or efficacy. To support its application, Regeneron submitted data from the pivotal Phase II ELM-2 study, which demonstrated an 80% objective response rate and a 73% complete response rate.
Despite this, the company has now decided to forego an accelerated approval pathway for DLBCL. “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,” a company spokesperson stated.
Rising Competition in the DLBCL Space
Regeneron has not specified which competitor developments influenced its decision, but recent progress by Roche and Genmab suggests a shifting landscape in the DLBCL market.

In December 2024, Roche announced that the FDA had accepted its supplemental application to expand the label of Columvi, a bispecific T-cell engager, for use with gemcitabine and oxaliplatin in relapsed or refractory DLBCL patients. The combination is now available to patients who have received at least one prior line of therapy and are ineligible for stem cell treatment.
Meanwhile, Genmab reported strong long-term data for its T-cell engager, epcoritamab. The company revealed a 100% objective response rate and an 87% complete response rate in high-risk, previously untreated DLBCL patients, with responses remaining durable over a median follow-up of 27.4 months.
Looking Ahead
With a priority review in place for FL, Regeneron remains focused on securing accelerated approval in that indication. For DLBCL, the company will wait for Phase III data before pursuing full regulatory approval, acknowledging the increasingly competitive field.