Posted by Michael Wonder on 31 Jan 2019
A review of patient reported outcomes labelling for oncology drugs approved by the FDA and the EMA (2012-2016)
31 January 2019 - In recent years, the FDA has granted patient-reported outcome labelling to very few oncology drugs.
Oncology drugs and indications approved between 2012 and 2016 by both the FDA and the EMA were identified. PRO-related language and analysis reported in US product labels and drug approval packages and EMA summaries of product characteristics were compared for each indication.
In total, 49 oncology drugs were approved for a total of 64 indications. Of the 64 indications, 45 (70.3%) included PRO data in either regulatory submission. No FDA PRO labelling was identified. PRO language was included in the summary of product characteristics for 21 (46.7%) of 45 indications.
