FDA Will Split Avapritinib GIST NDA Into Separate Submissions

October 28, 2019 – The FDA has informed Blueprint Medicines that it intends to split the proposed indications for its agent avapritinib into two separate new drug applications (NDAs) for patients with gastrointestinal stromal tumor (GIST): one for patients with PDGFRA exon 18–mutant disease regardless of prior therapy, and one for fourth-line GIST. Additionally, the FDA has requested topline findings from the phase III VOYAGER trial (NCT03465722) of avapritinib versus … (leggi tutto)