JPM: Regeneron has spoken with the FDA about odronextamab hold, hopes to get patients back soon

JPM: Regeneron has spoken with the FDA about odronextamab hold, hopes to get patients back soon

Source: 
Fierce Biotech
snippet: 

Regeneron’s chief scientific officer has told investors that the ball is in the FDA’s court after looking to “fulfill their need” to lift the enforced pause on its cancer study.

A month ago, the FDA told Regeneron to hit the brakes on its experimental blood cancer drug trial over safety concerns.

The U.S. regulator slapped a partial clinical hold on odronextamab, a CD20xCD3 bispecific antibody in tests for B-cell non-Hodgkin lymphoma, after the FDA said the company has to “further reduce the incidence of Grade 3 cytokine release syndrome (CRS),” a not uncommon safety issue in certain blood cancer trials but one that can be fatal.