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

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

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.

This has seen Regeneron pause new enrollment in the trial, allow treatment to continue for enrolled patients if they re-consent and send off a new protocol amendment to FDA, with the “goal of resuming patient enrollment in the first quarter of 2021.”

Speaking at the annual J.P. Morgan Healthcare Conference today, Regeneron CSO George Yancopoulos, M.D., Ph.D., said: “We have responded to the FDA with an approach that we hope will fulfill their need and that will allow us to go back to actively treating patients in this very important program.”

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