Odronextamab is a type of medication known as a bispecific antibody, which targets cancer cells by connecting them to immune cells.
Regeneron Pharmaceuticals is trying again to get fast-track approval from the US Food and Drug Administration (FDA) for odronextamab, specifically for treating a type of cancer called relapsed/refractory follicular lymphoma (r/r FL). The FDA will review Regeneron’s updated application and make a decision by July 30, 2025.
Regeneron’s first application was rejected in March 2024 because their Phase III trial, OLYMPIA-1, wasn’t progressing as expected. The FDA wanted the trial to be further along before granting accelerated approval. They also requested that Regeneron outline clear timelines for the trial’s progress.
To address these concerns, Regeneron met an enrolment target set by the FDA and resubmitted their application. This new submission is backed by earlier trials showing promising results, with 80% of patients responding to the treatment and 74% experiencing a complete response. However, some serious side effects, like cytokine release syndrome and pneumonia, were reported in less than 10% of patients.
If the FDA approves odronextamab, it will join other similar drugs in the US market, like AbbVie and Genmab’s Epkinly (epcoritamab). Odronextamab is already approved in Europe under the brand name Ordspono for treating certain types of lymphoma.
Overall, odronextamab represents a hopeful advancement in cancer treatment, aiming to harness the immune system to fight cancer more effectively.