China-based CStone Pharmaceuticals (HKG: 2616) announced that its Ayvakit (avapritinib), a tyrosine kinase inhibitor for treating gastrointestinal stromal tumors (GIST), has been included in Taiwan’s National Health Insurance, effective June 1, 2022.
Drug Approval and Background
Avapritinib received approval in Taiwan under the trade name TaiShiWei in 2021 for adult patients with unresectable or metastatic GIST with the PDGFRA D842V mutation. This marked the first targeted therapy for GIST with this specific mutation. The drug was previously recommended by the NCCN guidelines as a priority first-line treatment for adult patients with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations, including PDGFRA D842V.
Clinical Trial Results
The approval is based on the global Phase I NAVIGATOR study. For patients with PDGFRA D842V-mutated GIST, 36 of 38 patients who received a starting dose of 300/400 mg responded, resulting in an overall response rate (ORR) of 95%. Among the 28 patients who started on a 300 mg dose, 27 responded, achieving an ORR of 96%, with a disease control rate (DCR) of 100% across all dose groups. The median duration of response (DOR) reached up to 27.6 months.
Market Presence
Ayvakit is also marketed in the US, European Union, mainland China, and Hong Kong, underscoring CStone Pharmaceuticals’ expanding global footprint in oncology treatments.-Fineline Info & Tech
