On November 15, 2023 Foundation Medicine, Inc., and Pierre Fabre Laboratories reported a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOneCDx and FoundationOneLiquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC) (Press release, Foundation Medicine, NOV 15, 2023, View Source [SID1234637722]). The companies will work collaboratively to seek the regulatory approval for Foundation Medicine assays which detect mutations including BRAFV600E to identify patients for potential treatment with Pierre Fabre Laboratories’s BRAF/MEK inhibitor combination regimen, BRAFTOVI (encorafenib) and MEKTOVI (binimetinib), in the European Union. This combination therapy is currently under evaluation by the European Medicines Agency for patients with BRAFV600-mutant advanced NSCLC and was evaluated in a clinical trial sponsored by Pfizer and supported by Pierre Fabre.
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Lung cancer – the number one cause of cancer deaths worldwide – remains an area of high unmet need notably for those people living with BRAFV600E mutations, which occur in approximately 2% of all non-small cell lung cancer.1 FoundationOne CDx and FoundationOne Liquid CDx are U.S. Food and Drug Administration (FDA) approved in-vitro diagnostics used to identify potentially targetable mutations, including BRAF, in blood- and tissue-based solid tumor samples.
"Today, as the number of indications and approvals in oncology grow rapidly, companion diagnostics provide information that is critical for the safe and effective use of targeted therapies. And that’s why we are excited to work with Foundation Medicine," said Núria Perez-Cullell, Head of Medical and Patient Consumer Department, Pierre Fabre Laboratories. "Thanks to those companion diagnostics, physicians will have comprehensive, reliable information about what is driving a patient’s cancer, such as BRAFV600E mutations, so they can make personalized treatment decisions."
Foundation Medicine has the only FDA-approved portfolio of comprehensive genomic profiling tests offering physicians both blood- and tissue-based testing options for detecting genomic alterations like BRAFV600E to help guide personalized treatment decisions. Foundation Medicine has demonstrated initial success in navigating the new In Vitro Diagnostics Regulation (IVDR) in Europe through activation of dozens of global clinical studies or using patient samples from over 20 European Union member states in compliance with IVDR Authorization and Notification pathways.2
"High-quality companion diagnostics play a crucial role in helping physicians match their patients with targeted treatment options," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We are excited to support Pierre Fabre Laboratories in offering more treatment options for cancer patients, and to increase access to precision therapies in the European Union."