Thursday, November 16, 2023
Foundation Medicine and Pierre Fabre Laboratories have partnered to develop companion diagnostics for non-small cell lung cancer (NSCLC). The collaboration focuses on utilizing Foundation Medicine's genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, to identify patients who might benefit from new targeted therapies.
Specifically, the goal is to detect mutations, including BRAFV600E, to potentially qualify patients for treatment with Pierre Fabre Laboratories' BRAF/MEK inhibitor combination regimen, BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib), seeking approval in the European Union. These therapies are being evaluated for patients with BRAFV600-mutant advanced NSCLC. With lung cancer being a leading cause of global cancer-related deaths, the collaboration aims to address the specific challenges faced by individuals with BRAFV600E mutations, present in about 2% of all non-small cell lung cancer cases.
FoundationOne CDx and FoundationOne Liquid CDx are FDA-approved in-vitro diagnostics offering comprehensive genomic profiling for identifying targetable mutations like BRAFV600E in blood- and tissue-based samples. Foundation Medicine has successfully navigated the new In Vitro Diagnostics Regulation (IVDR) in Europe, conducting global clinical studies while adhering to IVDR Authorization and Notification pathways. The development of reliable companion diagnostics is crucial for physicians to effectively match patients with personalized treatment options.