• As a treatment decisions support, the expansion of companion diagnostic (CDx) portfolio will provide further value for patients and improve access to cancer treatments
• Chugai aims to further contribute to advancing cancer treatment by pursuing additional CDx indications

TOKYO, June 3, 2022 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) on June 2, 2022, for FoundationOne ^®CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) therapies, a tyrosine kinase inhibitor VIZIMPRO^® tablets (generic name: dacomitinib hydrate) and a tyrosine kinase inhibitor ALUNBRIG^® tablets (generic name: brigatinib), as well as for malignant melanoma therapies, a BRAF inhibitor BRAFTOVI^® capsules (generic name: encorafenib) and a MEK inhibitor MEKTOVI^® tablets (generic name: binimetinib).

“With a single test, FoundationOne CDx Cancer Genomic Profile can identify genomic alterations of each patient’s cancer comprehensively. This enables them to develop treatment plans tailored to the individual patients, realizing advanced personalized healthcare,” said Dr. Osamu Okuda, Chugai’s President and CEO. “We believe this portfolio expansion of companion diagnostics for four molecular-targeted drugs approved in Japan for the treatment of NSCLC and melanoma, will increase its value as a decision support and contribute to improved treatment access for patients with these types of cancer. We aim to further contribute to advancing cancer treatment by pursuing additional companion diagnostic indications.”

As a companion diagnostic, FoundationOne CDx Cancer Genomic Profile will be used to identify patients with activated EGFR alteration positive or ALK fusion gene positive NSCLC who may benefit from dacomitinib hydrate or brigatinib, respectively. It will also be used to identify patients with BRAF alteration positive malignant melanoma who may benefit from encorafenib and binimetinib combination.

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

Approval information The underlined part has been newly added.

Intended uses or indications

• The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
• The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.

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.