Posted by Michael Wonder on 16 Nov 2021
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: a comparison with standard approved cancer drugs
15 November 2021 - Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorisation.
Whether, when taking conditional marketing authorisation post-approval confirmatory trials into account, the level of evidence and clinical benefit between conditional marketing authorisation and standard approved drugs differs remains unknown.
