October 28, 2019
FDA splits proposed indications for Blueprint Medicines’ avapritinib into two separate NDAs
Blueprint Medicines Corporation said in an update on its New Drug Application (NDA) for avapritinib for the treatment of adults with PDGFRA , that the FDA has said it plans to administratively split the proposed indications for avapritinib into two separate NDAs, one for PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and one for fourth-line GIST.