Posted by Michael Wonder on 07 Feb 2020
Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour
6 February 2020 - PDUFA action date extended by three months to 14 May 2020.
Blueprint Medicines today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its new drug application seeking accelerated approval of avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumour.
The FDA extended the PDUFA action date by three months from 14 February 2020 to 14 May 2020.
