TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it obtained an approval from the Ministry of Health, Labour and Welfare (MHLW) for expanded use of the genomic mutation analysis program, FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of the Novartis' investigational MET inhibitor, capmatinib (INC280) for the treatment of unresectable advanced and/or metastatic non-small cell lung cancer (NSCLC) with that leads to MET exon 14 skipping (METex14).

'We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic of an investigational MET inhibitor, capmatinib. Since the standard treatment of NSCLC is decided based on whether the cancer has a driver mutation, we believe NSCLC is one of the cancer types that comprehensive genomic profiling can particularly contribute to its treatment decision,' said, Dr. Osamu Okuda, Chugai's President and COO. 'By continuing to collaborate with many biopharma partners, we will expand the companion diagnostic functions and are committed to working toward the realization of precision medicine.'

The approval aims to expand the program for use as a companion diagnostic to aid in identifying patients who could benefit from capmatinib for the treatment of unresectable advanced and/or metastatic NSCLC with METex14 by detecting mutations that lead to METex14. It is estimated that 3-4% of all patients with NSCLC have an identified METex141) and is said to be a poor prognosis factor2). Capmatinib is a selective MET inhibitor and is confirmed to strongly inhibit the kinase activity of the METex143). Efficacy and safety of capmatinib are investigated in patients with advanced and/or metastatic NSCLC in the phase II GEOMETRY mono-1 study conducted by Novartis. Novartis Japan K.K. has submitted the regulatory application of capmatinib to the MHLW.

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.

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

Contact:

Tomoko Shimizu

Tel: +81-3-3273-0881

Email: pr@chugai-pharm.co.jp

(C) 2020 Electronic News Publishing, source ENP Newswire