Chugai diagnostic approved in Japan to match lung cancer patients with Rozlytrek
The Roche (ROG: SIX) majority-owned subsidiary Chugai (TYO: 4519) has won Japanese approval of a diagnostic that it calls the FoundationOne CDx Cancer Genomic Profile.
This product has been approved as a companion diagnostic of Rozlytrek (entrectinib) for ROS1 fusion-positive non-small cell lung cancer (NSCLC).
The approval allows physicians to identify NSCLC patients who could benefit from the oral tyrosine kinase inhibitor by detecting ROS1 fusion genes. Chugai filed an application in Japan for this additional indication of Rozlytrek for the treatment of ROS1 fusion-positive, locally advanced or metastatic NSCLC on March 15, 2019, and it remains under regulatory review.
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