NEW YORK – Cstone Pharmaceuticals announced on Thursday that the companion diagnostic test codeveloped with Genetron for CStone's Ayvakit (avapritinib) has received approval from China's National Medical Products Administration.
The Human platelet-derived growth factor receptor alpha (PDGFRA) Gene D842V Mutation Detection Kit detects PDGFRA gene mutations in gastrointestinal stromal tumors (GIST) for patients receiving treatment with Ayvakit, CStone said in a statement. Ayvakit is approved by the NMPA to treat adults with unresectable or metastatic GIST that have the PDGFRA exon 18 mutation. The drug has also been approved by the US Food and Drug Administration for adults with indolent systemic mastocytosis, adults with advanced systemic mastocytosis, and adults with unresectable or metastatic GIST with a PDGFRA exon 18 mutation.
CStone and Genetron launched a multi-center clinical trial to develop a companion diagnostic for Ayvakit in 2020.
The kinase inhibitor was discovered by Blueprint Medicines, and CStone has an exclusive collaboration and license agreement with the company for the development and commercialization of Ayvakit in China, Hong Kong, Macau, and Taiwan.