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Japanese Regulator Approves Foundation Medicine CDx for Roche's Rozlytrek in Lung Cancer

NEW YORK – Chugai Pharmaceutical, a subsidiary of Roche, announced late last month that Japan's Ministry of Health, Labor, and Welfare has granted additional approval of Foundation Medicine's FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for entrectinib (Roche's Rozlytrek), marketed in Japan by Chugai.

The diagnostic is now approved for the detection of ROS1 fusion genes in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The approval will allow clinicians to identify NSCLC patients who could benefit from treatment with entrectinib by detecting ROS1 fusions.

The FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing-based test from Roche's Foundation Medicine and is used for detecting and analyzing substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures such as microsatellite instability and tumor mutational burden.

Chugai said it filed an application for this additional indication of entrectinib for the treatment of ROS1 fusion-positive, locally advanced or metastatic NSCLC in March 2019. The Roche subsidiary received approval from Japanese regulators for the drug for the treatment NTRK fusion-positive advanced or recurrent solid tumors in June 2019 and received additional approval for the use of the companion diagnostic later that month.

The Foundation Medicine test was previously approved by Japanese regulators in December 2018 as a comprehensive genomic profiling test for all solid tumors and as a companion diagnostic for advanced cancer patients.

"We are pleased that the FoundationOne CDx Cancer Genomic Profile is now approved as a companion diagnostic against ROS1 fusion gene, which is one of the driver mutations in NSCLC. Although the frequency of ROS1 fusion gene expression in NSCLC is only about 1 to 2 percent, treatment using ROS1 inhibitors can become one of the important therapeutic options for patients with ROS1-positive cancer," Minoru Watanabe, Chugai vice president and head of the Foundation Medicine unit, said in a statement. "I am convinced that comprehensive cancer genomic profiling can further contribute to patients by enhancing its companion diagnostic functions. We will further expand companion diagnostic functions for both our in-house products and collaborations with biopharma partners."