Regeneron's odronextamab hit with FDA partial hold on lymphoma trials

 

• The FDA has put a partial clinical hold on Regeneron's (REGN -1.4%) odronextamab, a CD20xCD3 bispecific antibody its experimental blood cancer drug trial, over safety concerns. It asked the company to change protocols to reduce the occurrence of an inflammatory response called cytokine release syndrome.
• This will hit enrollment in a Phase 1 monotherapy trial in B-cell non-Hodgkin lymphoma (B-NHL) as well as another mid-stage trial testing the drug in sub-types of B-NHL.
• Though new enrollment will be paused, treatment for enrolled patients will continue if they re-consent.
• Regeneron said it planned to submit the details of a new protocol amendment to FDA, with the goal of resuming enrollment in Q1 of 2021.
• https://seekingalpha.com/news/3644594-regenerons-odronextamab-hit-fda-partial-hold-on-lymphoma-trials