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Chugai Gains Japanese Approval for CDx for Eli Lilly's Retevmo

NEW YORK – Chugai Pharmaceutical announced on Thursday that Japan's Ministry of Health, Labour, and Welfare has approved Roche's FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Eli Lilly Japan's Retevmo capsules (selpercatinib) for rearranged during transfection (RET) fusion-positive solid tumors. 

The next-generation sequencing-based test can be used for comprehensive genomic profiling of tumor tissues in patients with solid cancers to determine if Retevmo should be used for RET fusion-positive solid tumors, Chugai noted in a statement. Chugai is a member of the Roche Group. 

"We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for selpercatinib, a cancer therapeutic drug for a rare RET fusion gene," Chugai President and CEO Osamu Okuda said in a statement. "It is useful for smooth consideration of treatment plans for patients because it can diagnose with a single test, including extremely rare genetic mutations that are found to be expressed across cancer types."

The test detects 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, using DNA isolated from tumor tissue specimens. Earlier this month, the assay received Japanese regulatory approval for use as a companion diagnostic with Pfizer's Talzenna capsules (talazoparib tosylate).