BRIEF—Bluepint Medicines' Ayvakit set for priority review in China

Blueprint Medicines' Ayvakit (avapritinib), a treatment for gastrointestinal stromal tumors (GIST), was put on the list for priority review by China's Center for Drug. Evaluation (CDE).

Approved in the USA in January, the drug is under pivotal studies in China by Blueprint's Chinese partner CStone Pharmaceuticals.

The Suzhou-based company in-licensed the Greater China rights to avapritinib, BLU554 and BLU667 from Blueprint in 2018.

The China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) of the precision therapy avapritinib for two indications in April this year.

One indication is for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations; the other is for the treatment of adults with unresectable or metastatic fourth-line GIST.