NEW YORK – Chinese diagnostic firm Amoy Diagnostics announced on Wednesday that it has entered into a collaboration agreement with French pharmaceutical firm Pierre Fabre to develop companion diagnostic kits in China.
The kits will support marketing authorization applications for Pfizer's Braftovi (encorafenib) and Mektovi (binimetinib), Amoy said in a statement. Neither drug is registered in China, Amoy said, but Pierre Fabre has been granted exclusive rights to commercialize the treatments in Europe and Asia, excluding Japan and South Korea.
The companion diagnostic kits, which detect BRAF mutations in tumor samples, are currently being validated for use with the two drugs in two Chinese studies, Amoy added.
In the EU and US, a combination of Braftovi and Mektovi is indicated to treat adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Braftovi is also indicated in combination with Eli Lilly's Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation who have received prior systemic therapy.