European CHMP negative opinion of eflornithine/sulindac (Flynpovi) for treatment of adults with familial adenomatous polyposis (FAP)

Negative opinion based on failure to show that Flynpovi: delays the occurrence of first FAP-related event compared to eflornithine or sulindac monotherapy; was not compared to standard of care or placebo; and there is insufficient long-term data including genotoxic data.

Source:

European Medicines Agency