The latest FDA approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.

The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.