Regeneron Resumes Enrollment for Lymphoma Drug Trials
Regeneron is restarting patient enrollment for two studies evaluating its investigational lymphoma drug, odronextamab, after the FDA lifted partial holds on the clinical trials.
The phase 1 and 2 studies assessing the therapy for follicular lymphoma and diffuse large B-cell lymphoma were paused in December after the FDA called for a change in the protocol following reports of cytokine release syndrome in some participants.
Odronextamab is a bispecific monoclonal antibody and antitumor agent that binds to T-cells and to malignant B-cells. Cytokine release syndrome, a sometimes fatal inflammatory response, is a known side effect of certain cancer therapies that bind to the CD3 proteins and co-receptors on T-cells.