Posted by Michael Wonder on 22 May 2018
EMA report makes recommendations for CAR-T patient registries
22 May 2018 - A new report from the EMA lays out recommendations for improving the use of patient registries to support the benefit-risk evaluation of chimeric antigen receptor (CAR) T-cell therapies.
The report comes as EMA considers whether to approve the first batch of CAR T-cell products submitted to it for marketing authorisation, including applications for Kite’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel), both of which have already been approved in the US.
The recommendations in the report are based on input EMA received at a workshop in February that included stakeholders from industry, patient representatives, national regulators and two large registry owners as part of the agency’s patient registry initiative.
