Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Alecensa for ALK Fusion Gene-Positive Solid Tumors

TOKYO, May 18, 2026 –– Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on March 9, 2026 for FoundationOne^®CDx Cancer Genomic Profile to be used as a companion diagnostic for Alecensa^® (generic name: alectinib), an anti-cancer agent/ALK inhibitor for ALK fusion gene-positive solid tumors.

This approval enables the detection of ALK fusion gene using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use Alecensa for ALK fusion gene-positive solid tumors. The efficacy and safety of Alecensa for advanced or recurrent ALK fusion gene-positive solid tumors were evaluated in an investigator initiated Japanese Phase II clinical study (TACKLE study), and an approval for a partial change to the marketing authorization was obtained on May 18, 2026.

FoundationOne CDx Cancer Genomic Profile has continuously expanded its tumor-agnostic companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment plans for multiple medicines. With the addition of Alecensa as a companion diagnostic for ALK fusion gene-positive solid tumors, beyond its already approved use in non-small cell lung cancer, the potential treatment options for patients with solid tumors are expected to expand. As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling.

Approval information The underlined and bolded 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.

[Reference]

Alecensa Receives the World-First Tumor-Agnostic Approval for ALK Fusion Gene-Positive Solid Tumors Across Adult and Pediatric Patients (Press release dated May 18, 2026)
https://www.chugai-pharm.co.jp/english/news/detail/20260518153001_1249.html

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.