TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 28, 2024, for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Eli Lilly Japan K.K.'s RET receptor tyrosine kinase inhibitor, Retevmo capsules (generic name: selpercatinib), for RET fusion-positive solid tumors.

'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. 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,' said Chugai's President and CEO, Dr. Osamu Okuda.

This approval enables the detection of RET fusion genes using the FoundationOne CDx Cancer Genome Profile to assist of the decision to use selpercatinib for RET fusion-positive solid tumors. The efficacy and safety of selpercatinib for RET fusion-positive solid tumors was evaluated in the LIBRETTO-001 Phase 1/2 study. Eli Lilly Japan K.K. is currently applying to the MHLW for additional indications.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genome Profile.

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.

Contact:

Hideki Sato

Tel: +81-3-3273-0881

Email: pr@chugai-pharm.co.jp

Takayuki Sakurai

Tel: +81-3-3273-0554

Email: ir@chugai-pharm.co.jp

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