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CStone, Blueprint Medicines' Ayvakit Nets Hong Kong Approval for Biomarker-Defined GIST

NEW YORK – CStone Pharmaceuticals said on Tuesday that the Hong Kong Department of Health has approved avapritinib (Ayvakit) as a treatment for PDGFRA D842V-mutated gastrointestinal stromal tumors (GIST).

Specifically, avapritinib — which was initially a discovery of Blueprint Medicines — will now be available in Hong Kong as a treatment for patients with unresectable or metastatic GIST. Hong Kong regulators approved avapritinib based on results of the Phase I NAVIGATOR study, in which the overall response rate among 38 patients with PDGFRA D842V-mutant GIST was 95 percent and the disease control rate was 100 percent. The median duration of response was 27.6 months.

In 2020, avapritinib also garnered US Food and Drug Administration approval and conditional European Commission authorization for molecularly defined GIST, and the agent was likewise approved for the patient population in mainland China and Taiwan earlier this year.

Following a collaboration and license agreement, CStone has the exclusive rights to develop and commercialize avapritinib in mainland China, Hong Kong, Macau, and Taiwan, whereas Blueprint retains the rights to develop and commercialize the drug in the rest of the world.