Thread by @oncology_bg

Very happy to see this announcement today from @FDAOncology . Early approval based on surrogate and appropriate action upon failure to confirm clinical benefit in confirmatory trial is the mandate of accelerated approval. fda.gov/news-events/fd…

Several of our works @PORTAL_Research have previously highlighted that this follow-through has not been happening. Failure to act when drugs fail to improve clinical benefit in confirmatory trials breaks the social compromise of AA. I will share 2 imp papers in this regard.

First, in this @JAMAInternalMed paper we published last year, we show that confirmatory trials do not confirm clinical benefit using survival endpoints and even when confirmatory trials fail, no actions are usually taken. jamanetwork.com/journals/jamai… @akesselheim

Second, in this @NatRevClinOncol paper, we discuss why not completing confirmatory trials in time and not taking action when confirmatory trials fail break the social compromise of accelerated approval. nature.com/articles/s4157… @akesselheim

So, this decision by the FDA to review these drug-indications where confirmatory trials have failed to confirm clinical benefit is a very positive step. fda.gov/news-events/fd…