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Foundation Medicine Advances Patient Access to Precision Medicine; Pursues Regulatory Approval for FoundationOne CDx™ in JapanFoundation Medicine, Inc. (NASDAQ:FMI) today announced that Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519), one of Japan's leading research-based pharmaceutical companies and a member of the Roche Group, will broaden patient access to Foundation Medicine's comprehensive genomic profiling (CGP) services for individuals with advanced cancer. Specifically, Chugai has filed for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for FoundationOne CDx™, which, if approved in Japan, would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan. Chugai will also lead commercial efforts in Japan for Foundation Medicine's suite of CGP assays. FoundationOne CDx is the first FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics. If approved in Japan by the MHLW, Chugai will be the Marketing Authorization Holder of FoundationOne CDx in Japan. "Seeking approval for FoundationOne CDx in Japan is an important step for the integration of comprehensive genomic profiling into oncology clinical care," said Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. "Importantly, an MHLW-approved assay could enable the same accelerated pathway for companion diagnostic development and approval that Foundation Medicine has pioneered in the United States with FDA approval, meeting a critical need today for our biopharma partners' global development and commercial efforts. We look forward to partnering with Chugai, and our biopharma partners, to expand MHLW-approved companion diagnostics claims on FoundationOne CDx ensuring patient access to personalized cancer care." FoundationOne CDx assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is indicated for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. The first FDA-approved test of its kind for all solid tumors, FoundationOne CDx is a diagnostic test that acts as: a broad companion diagnostic for patients who may benefit from treatment with specific FDA-approved targeted therapies; a CGP test that includes genomic biomarkers such as microsatellite instability (MSI (News - Alert)) and tumor mutational burden (TMB), to help inform the use of other targeted oncology therapies, including immunotherapies; a tool for physicians that identifies patient opportunities for clinical trial participation; and, an FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics. "This collaboration further enables us to pursue personalized oncology care in Japan," said Tatsuro Kosaka, Chugai's president and chief operating officer. "Regulatory approval for FoundationOne CDx would establish validation for the assay in Japan. We're excited to collaborate with Foundation Medicine to change the cancer care treatment paradigm in Japan." Japan represents the fourth largest addressable market for next generation sequencing in oncology following the United States, China and Germany. The country accounts for approximately 9% of all global oncology costs. Approximately 52% of all oncology drugs approved globally between 2011-2015 are availble in Japan.1
About FoundationOne CDx
About Foundation Medicine
About Chugai In Japan, Chugai's research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai's proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2017 of Chugai totaled 534.2 billion yen and the operating income was 103.2 billion yen (IFRS Core basis). Additional information is available on the internet at https://www.chugai-pharm.co.jp/english/. Foundation Medicine® is a registered trademark and FoundationOne CDx™ is a trademark of Foundation Medicine, Inc.
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Medicine 1 Global Oncology Trends 2017. Report by the QuintilesIMS Institute View source version on businesswire.com: http://www.businesswire.com/news/home/20180315006555/en/ |