Blueprint Medicines gets FDA nod for GI stromal tumor drug Ayvakit

The US Food and Drug Administration has approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

Ayvakit, developed by rare and cancer diseases specialist Blueprint Medicines (Nasdaq: BPMC) and is the company’s first product, is the first precision therapy approved to treat a genomically defined population of patients with GIST.

Even though the accelerated market clearance came around five weeks earlier than the expected February 14 FDA action date, Blueprint’s shares were barely moved yesterday nor in pre-market trading today.