25 March 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued complete response letters for the biologics license application for odronextamab in relapsed/refractory follicular lymphoma and in relapsed/refractory diffuse large B-cell lymphoma, each after two or more lines of systemic therapy. 

The only approvability issue is related to the enrollment status of the confirmatory trials. The letters – one for relapsed/refractory follicular lymphoma and one for relapsed/refractory diffuse large B-cell lymphoma – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing.

Read Regeneron Pharmaceuticals press release