FDA Grants Priority Review to Avapritinib for GIST

Aug 7, 2019 – The FDA has granted a priority review designation to a new drug application (NDA) for avapritinib for the treatment of adult patients with PDGFRA exon 18–mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, as well as for patients with GIST in the fourth-line setting. Under the Prescription Drug User Fee Act, the FDA must make a decision on the NDA by February 14, 2020. “Patients with PDGFRA exon 18 mutant GIST and fourth-line … (leggi tutto)