BioCentury
ARTICLE | Company News

Blueprint gets first FDA approval, with second expected this year

January 9, 2020 11:57 PM UTC

FDA approved Blueprint’s gastrointestinal stromal tumor therapy a month ahead of its Feb. 14 PDUFA date, notching the biotech the first of two expected approvals this year.

Ayvakit avapritinib from Blueprint Medicines Corp. (NASDAQ:BPMC) is indicated for unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, which is involved in up to 10% of GIST cases. The drug, which inhibits c-Kit and PDGFRA mutant kinases, is the first therapy approved for a genomically defined GIST population...