On March 29, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for expanded use of "FoundationOne CDx Cancer Genomic Profile," a next-generation sequencing based program currently under preparation for launch, to include as a companion diagnostic using tumor tissue specimens for PARP inhibitor "Lynparza" (generic name: olaparib) (Press release, Chugai, MAR 29, 2019, View Source [SID1234534748]).

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The filing aims to expand the program for use as a companion diagnostic to identify people that could potentially benefit from Lynparza for the maintenance treatment of adult patients with advanced ovarian cancer in complete or partial response to first-line platinum-based chemotherapy who have tumor mutations in BRCA1/2 based on the SOLO-1 Phase 3 randomized trial results.

FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program was approved by the MHLW in December 2018 as the first cancer genomic test in Japan with the two functions of cancer genomic profiling and companion diagnostics for molecular-targeted drugs.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

[Notes]
A press release issued on December 27, 2018: Chugai Obtains Approval for Genomic Mutation Analysis Program "FoundationOne CDx Cancer Genomic Profile"
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