December 14, 2020 I Regeneron is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials for odronextamab, a CD20xCD3 bispecific antibody, in compliance with a U.S. Food and Drug Administration (FDA) partial clinical hold. The FDA requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. Currently enrolled patients who are deriving clinical benefit from odronextamab may continue treatment following re-consent.
Patient safety is of the utmost concern to Regeneron. The company plans to submit a protocol amendment to the FDA with the goal of resuming patient enrollment early in the first quarter of 2021.
The two trials currently enrolling patients that are impacted are a Phase 1 monotherapy trial in B-NHL and chronic lymphocytic leukemia and a Phase 2 monotherapy trial in several B-NHL subtypes.
SOURCE: Regeneron Pharmaceuticals
Post Views: 40
December 14, 2020 I Regeneron is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials for odronextamab, a CD20xCD3 bispecific antibody, in compliance with a U.S. Food and Drug Administration (FDA) partial clinical hold. The FDA requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. Currently enrolled patients who are deriving clinical benefit from odronextamab may continue treatment following re-consent.
Patient safety is of the utmost concern to Regeneron. The company plans to submit a protocol amendment to the FDA with the goal of resuming patient enrollment early in the first quarter of 2021.
The two trials currently enrolling patients that are impacted are a Phase 1 monotherapy trial in B-NHL and chronic lymphocytic leukemia and a Phase 2 monotherapy trial in several B-NHL subtypes.
SOURCE: Regeneron Pharmaceuticals
Post Views: 40
