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Japanese Health Ministry Clears Thermo Fisher Scientific Oncomine Assay as CDx for Lung Cancer Drug

NEW YORK – Thermo Fisher Scientific said on Friday that the Japan Ministry of Health, Labour and Welfare (MHLW), Japan's regulatory agency, has granted approval to the company's Oncomine Dx Target Test to be used as a companion diagnostic to identify patients with RET-fusion positive non-small cell lung cancer (NSCLC) who may be candidates for treatment with Eli Lilly's selpercatinib (formerly known as LOXO-292).

The MHLW granted orphan drug designation for selpercatinib, a tyrosine kinase inhibitor that selectively binds to the RET receptor, in 2020, Thermo Fisher said.

The Oncomine Dx Target Test is a next-generation sequencing assay that was first approved by the US Food and Drug Administration as a CDx in 2017, and it is now approved for four targeted therapies for non-small cell lung cancer and one targeted therapy for cholangiocarcinoma in the US.

In Japan, the test is approved for five biomarkers with a total of 10 associated targeted therapies for NSCLC patients, including as a CDx for dabrafenib (Novartis' Tafinlar) in combination with trametinib (Novartis' Mekinist), searching for BRAF V600E mutations; for afatinib (Boehringer Ingelheim's Gilotrif), gefitinib (AstraZeneca's Iressa), erlotinib (Genentech's Tarceva), and osimertinib (AstraZeneca's Tagrisso) searching for EGFR mutations; for alectinib (Chugai Pharmaceutical's Alecensa) and crizotinib (Pfizer's Xalkori) searching for ALK fusions; for crizotinib and entrectinib (Genentech's Rozlytrek) searching for ROS1 fusions; and now for selpercatinib searching for RET fusions.

"This approval will help patients suffering from non-small cell lung cancers whose tumors are positive for fusions in the RET receptor, providing access to new, potentially more effective treatments," Hiroo Murota, vice president and general manager of Thermo Fisher Scientific Japan, said in a statement. "We will continue to advance precision medicine by expanding our companion diagnostic tests that identify biomarkers associated with targeted therapies."

Late last month, Oncomine Dx was granted pre-market approval by the FDA as a CDx to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for treatment with ivosidenib (Servier Pharmaceuticals' Tibsovo).