Thermo Fisher’s Oncomine Dx target test approved in Japan as CDx for Lilly’s selpercatinib
13 Sep 2021
Orphan Drug
Oncomine Dx Target Test is a next-generation sequencing (NGS)-based assay, initially approved by the US FDA in 2017
Oncomine Dx target test approved in Japan. (Credit: Thermo Fisher Scientific Inc.)
Thermo Fisher Scientific has received the Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Oncomine Dx Target Test as a companion diagnostic (CDx) for lung cancer drug.
The CDx was indicated for patients with RET-fusion positive non-small-cell lung cancer (NSCLC), who are eligible for Lilly’s selpercatinib, previously called LOXO-292.
Selpercatinib is a tyrosine kinase inhibitor that selectively binds to the RET receptor, and was granted the orphan drug designation from the MHLW last year.
Oncomine Dx Target Test is a next-generation sequencing (NGS) based assay that was first approved by the US Food and Drug Administration (FDA) in 2017.
The test is currently approved in the US for four targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma.
Thermo Fisher Scientific Japan vice president and general manager Hiroo Murota said: “This approval will help patients suffering from non-small cell lung cancers whose tumours are positive for fusions in the RET receptor, providing access to new, potentially more effective treatments.
“We will continue to advance precision medicine by expanding our companion diagnostic tests that identify biomarkers associated with targeted therapies.”
Thermo Fisher currently offers NGS-based CDx solution approved in more than 15 countries, including the US, EU member states, Japan, South Korea and the Middle East.
Oncomine Dx Target Test has been approved in Japan for five biomarkers with a total of ten related targeted therapies for NSCLC patients.
The biomarkers include BRAF V600E mutation, EGFR mutations, ALK fusions, ROS1 fusions, and RET fusions.
The therapies include dabrafenib in combination with trametinib, afatinib, gefitinib, erlotinib, Osimertinib, alectinib, crizotinib, entrectinib, and selpercatinib.
In September last year, Thermo Fisher secured the FDA pre-marketing approval for its Oncomine Dx Target Test as a CDx to identify RET fusion-positive, metastatic NSCLC in patients eligible for GAVRETO (pralsetinib) treatment.
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