中外制药 FoundationOne CDx 获日本批准，作为辉瑞 LORBRENA（lorlatinib）治疗 ALK 融合基因阳性非小细胞肺癌的伴随诊断
Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Lorlatinib for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer
中外制药宣布，日本厚生劳动省于 2026 年 9 月 10 日批准 FoundationOne CDx 癌症基因组检测作为辉瑞日本第三代 ALK 抑制剂 LORBRENA 片剂（通用名 lorlatinib）的伴随诊断，用于 ALK 融合基因阳性非小细胞肺癌，通过检测 ALK 融合基因辅助判断 lorlatinib 用药。
TOKYO, September 18, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on September 10, 2026 for FoundationOne®CDx Cancer Genomic Profile to be used as a companion diagnostic for Pfizer Japan Inc’s third-generation ALK inhibitor, LORBRENA® tablets 25 mg and 100 mg (generic name: lorlatinib), which is approved for ALK fusion gene-positive non-small cell lung cancer (NSCLC).
This approval enables the detection of ALK fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use lorlatinib for ALK fusion gene-positive NSCLC.
FoundationOne CDx Cancer Genomic Profile has continuously expanded its companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment decisions for multiple medicines. With this approval, the availability of companion diagnostics for ALK fusion gene-positive NSCLC will be further expanded, which is expected to enhance patient access to appropriate treatment options.
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.
| Alterations | Cancer type | Relevant drugs |
|---|---|---|
| Activated EGFR alterations | Non-small cell lung cancer (NSCLC) | afatinib, erlotinib, gefitinib, osimertinib |
| EGFR exon 20 T790M alterations | osimertinib | |
| ALK fusion genes | alectinib, crizotinib, ceritinib, brigatinib, lorlatinib | |
| ROS1 fusion genes | entrectinib | |
| MET exon 14 skipping alterations | capmatinib | |
| BRAF V600E and V600K alterations | Malignant melanoma | dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib |
| BRAF V600 alterations and BRAF fusion genes | Glioma | tovorafenib |
| ERBB2 copy number alterations (HER2 gene amplification positive) | Breast cancer | trastuzumab |
| AKT1 alterations | capivasertib | |
| PIK3CA alterations | ||
| PTEN alterations | ||
| KRAS/NRAS wild-type | Colorectal cancer | cetuximab, panitumumab |
| Microsatellite instability high | nivolumab | |
| Microsatellite instability high | Solid tumors | pembrolizumab |
| Tumor mutational burden high | pembrolizumab | |
| NTRK1/2/3 fusion genes | entrectinib, larotrectinib, repotrectinib | |
| RET fusion genes | selpercatinib | |
| ALK fusion genes | alectinib | |
| BRCA1/2 alterations | Ovarian cancer | olaparib |
| BRCA1/2 alterations | Prostate cancer | olaparib |
| FGFR2 fusion genes | Biliary tract cancer | pemigatinib |
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.
Trademarks used or mentioned in this release are protected by law.
来源：Chugai 中外制药｜中外制药 · chugai-pharm.co.jp