Odronextamab is a type of medicine called a bispecific antibody that targets proteins CD20 and CD3. Regeneron Pharmaceuticals is trying again to get approval from the US Food and Drug Administration (FDA) for using odronextamab to treat relapsed or refractory follicular lymphoma, a type of blood cancer. The FDA plans to make a decision by July 30, 2025.
Regeneron’s first application was turned down in March 2024 because the FDA had concerns about the progress of a key study called OLYMPIA-1. The FDA wanted to see more progress in this study before granting approval. They also wanted clear timelines for the study’s progress.
The FDA has since clarified what they expect from such confirmatory trials, including having a clear and active timeline and showing that patient enrolment is underway.
Regeneron has now resubmitted their application, saying they have met the enrolment targets the FDA wanted for the OLYMPIA-1 study. This study aims to recruit 478 patients. The resubmission is also backed by earlier studies that showed positive results, with an 80% response rate in patients.
If odronextamab gets approved, it would be one of the few treatments of its kind available in the US. Similar medicines include Epkinly (epcoritamab) by AbbVie and Genmab. Odronextamab works by connecting cancer cells with immune cells to help the body fight the cancer. It has already been approved in Europe under the name Ordspono for certain types of lymphoma.