CStone Files Taiwan NDA for Precision-Med GIST Candidate
publication date: Mar 27, 2020
Suzhou CStone Pharma filed an NDA in Taiwan for avapritinib, a precision therapy for gastrointestinal stromal tumors (GIST). The candidate is indicated for adult patients with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Avapritinib produced an ORR of 84% in the patient population against a 0% ORR for other TKI drugs. In 2018, CStone in-licensed greater China rights to avapritinib in a $386 million, three-drug deal with Blueprint Medicines of Cambridge, MA. More details....
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