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FDA lifts partial clinical hold on odronextamab trials in B-cell non-Hodgkin lymphomas
By Claire Baker
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On December 14, 2020, it was reported that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on trials of odronextamab in B-cell non-Hodgkin lymphomas (B-NHL) following reports of Grade ≥3 cytokine release syndrome during step-up dosing.
On May 17, 2021, the FDA announced the lift of this partial hold, meaning that enrollment of patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) to the affected trials, NCT02290951 (phase I) and NCT03888105 (phase II), will resume with immediate effect. The decision is based on the refined trial protocols that aim to further reduce the incidence of severe CRS.
- Regeneron Pharmaceuticals. Regeneron resumes enrollment of FL and DLBCL patients in odronextamab trials. https://investor.regeneron.com/static-files/f926fedf-8c6c-4f6f-a110-f295978c0c7f. Published May 17, 2021. Accessed May 19, 2021.
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