Agenus withdraws cervical cancer application, and a behind the scenes David vs. Big Pharma regulatory battle is revealed

Agenus’ cervical cancer drug balstilimab seemed on its way to FDA approval, but the biotech is now pulling the application after the agency granted full approval to Merck’s Keytruda in the same indication.

The biotech said in a statement released today that a filing for the approval of balstilimab is being voluntarily withdrawn, but according to a source with knowledge of the decision, the FDA pushed Agenus into a corner and recommended that the request be retracted.