FDA Denies Blueprint’s NDA for Stomach Cancer Treatment

The FDA has turned down a new drug application (NDA) from Blueprint Medicines for Ayvakit (avapritinib) for treatment of  adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST).

The agency approved the drug in January for treatment of GIST patients with a  platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, a genetic alteration found in about 10 percent of GIST cases.

The company said it will continue to commercialize the drug for GIST patients with the exon 18 mutation.