TOKYO, October 2, 2020 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for the expanded use of FoundationOne^® CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the fibroblast growth factor receptor (FGFR) inhibitor pemigatinib for patients with FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma on September 30,2020.

“Cholangiocarcinoma is a disease with high unmet medical needs that has limited treatment options. Currently, FGFR2 is identified as a driver gene for cholangiocarcinoma and molecular-targeted therapies are being evaluated to treat the disease,” said Dr. Osamu Okuda, Chugai’s President and COO. “We are committed to obtaining approval of FoundationOne CDx Cancer Genomic Profile as a CDx of pemigatinib as early as possible in order to contribute to treatment approaches for patients with the disease.”

The filing aims to expand the use as a companion diagnostic to identify patients who could benefit from pemigatinib for the treatment of FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma by detecting FGFR2 fusion genes. Incyte Biosciences Japan submitted an application for pemigatinib for the treatment of FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma to the MHLW on September 14, 2020. The MHLW designated pemigatinib as an orphan drug for the indication.

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

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., 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 is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About FGFR
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

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