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# FDA Lifts Hold on Regeneron’s Odronextamab Trials
- URL: https://www.fdaweb.com/fda-lifts-hold-on-regenerons-odronextamab-trials/
- Published: 2021-05-18T12:00:00.000Z
- Updated: 2026-09-14T16:59:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149346

FDA has lifted a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse large B-cell lymphoma. Trial protocols have been amended to further reduce the incidence of Grade 3 or greater cytokine release syndrome during step-up dosing, the company says, adding that it will recommence enrollment in these patient cohorts immediately (trials NCT02290951 and NCT03888105). The company describes odronextamab as a CD20xCD3 bispecific antibody.