Posted by Michael Wonder on 30 Aug 2023
Withdrawn accelerated approvals for cancer indications in the US: what is the marketing authorisation status in the EU?
30 August 2023 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US FDA since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years.
The marketing authorisation status of these indications in the EU has not been reported.
