Posted by Michael Wonder on 18 May 2020
Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug
18 May 2020 - The FDA has turned down Blueprint Medicines’ Ayvakit for more general use in gastro-intestinal stromal tumour after approving the drug in a narrower group of patients earlier this year.
The split decision for the drug has emerged because the FDA opted to review Blueprint’s marketing application for Ayvakit (avapritinib) in two parts.
The first part – which was approved in January – covered the use of the drug in GIST patients with a platelet-driven growth factor receptor alpha (PDGFRa) exon 18 mutation, including PDGFRA D842V mutations.
