On May 26, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 25, 2023, for FoundationOneLiquid CDx Cancer Genomic Profile to be used as a companion diagnostic for an anti-cancer agent/MET inhibitor, Tabrecta (generic name: capmatinib hydrochloride hydrate) of Novartis Pharma K.K. (Novartis), which is approved for the treatment of MET exon 14 skipping mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC) (Press release, Chugai, MAY 26, 2023, View Source;category= [SID1234632087]). With this approval, patients with advanced NSCLC who may be eligible for treatment with capmatinib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests.
"We are pleased that FoundationOne Liquid CDx Cancer Genomic Profile was approved as a companion diagnostic for capmatinib for advanced and/or recurrent unresectable NCSLC, in addition to the currently approved tissue-based FoundationOne CDx Cancer Genomic Profile," said Chugai’s President and CEO, Dr. Osamu Okuda. "Obtaining tissue samples can be a challenge for patients with NSCLC. Therefore, blood-based testing is an important option when considering treatment options for patient care. We are committed to advancing personalized healthcare by continuing to collaborate with many biopharma partners."
With this approval FoundationOne Liquid CDx Cancer Genomic Profile can be used as a companion diagnostic for capmatinib in advanced and/or recurrent unresectable NSCLC. It identifies patients eligible for the treatment by detecting MET exon 14 skipping gene alterations. The efficacy and safety of capmatinib in patients with advanced and/or metastatic NSCLC patients with MET exon 14 skipping alterations were investigated in the Phase II GEOMETRY mono-1 study conducted by Novartis. Novartis received approval from the MHLW in June 2020 for commercialization.
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 CGP.
Approval information The underlined part has been newly added.
Intended uses or indications
The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
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 dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing-based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through the detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report alterations (substitutions, insertion/deletion and select gene rearrangements) for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in the Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the approval information.
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