The US Food and Drug Administration (FDA) has accepted the priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals’ odronextamab.

The Prescription Drug User Fee Act (PDUFA) action date has been set for 31 March 2024. Regeneron aims for odronextamab, a CD20xCD3 bispecific antibody, to be approved as a third-line therapy in adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL).

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The regulatory journey for odronextamab has not been smooth sailing. In 2020, the FDA instituted a partial clinical hold on enrolling B-cell non-Hodgkin lymphoma (B-NHL) patients in trials evaluating odronextamab. The FDA put a clinical hold on the trials due to the high incidence of over Grade 3 cytokine release syndrome (CRS) in participants during step-up dosing. Following this, the company had to amend its trial protocols before resuming trials. The partial hold was lifted in May 2021. Odronextamab has previously received orphan drug designation and fast track designation from the FDA. The drug is expected to generate $616m in global sales in 2029, as per GlobalData.

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A marketing authorisation application for odronextamab is also under evaluation with the European Medicines Agency for the same indication and supporting data as the FDA application.

Regeneron’s BLA is supported by Phase I and II trial data. The data from the pivotal Phase II trial showed an overall response rate of 81% in R/R patients with Grade I–IIIa FL, with a median progression-free survival (mPFS) of 20.2 months.

The company also plans to initiate a Phase III trial for odronextamab, which evaluates the drug in earlier lines of therapy and in other BB-NHLs, apart from FL and DLBCL.

Other bispecific antibodies in Regeneron’s pipeline include linvoseltamab, which is a B-cell maturation antigen (BCMA) and CD3-targeting bispecific antibody. It is in Phase II clinical trials and is being evaluated as a fourth-line therapy for multiple melanoma.