Foundation Medicine has collaborated with Pierre Fabre Laboratories for the development of companion diagnostics for non-small cell lung cancer (NSCLC).
The partnership will focus on developing the FoundationOne CDx and FoundationOneLiquid CDx genomic tests as companion diagnostics for new targeted therapies to treat NSCLC patients.
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The companies aim to receive regulatory approval for the Foundation Medicine assays, which identify mutations, including BRAFV600E, for detecting patients to treat with Pierre Fabre’s BRAF/MEK inhibitor combination regimen, BRAFTOVI (encorafenib) and MEKTOVI (binimetinib), in the European Union.
Presently, this combination therapy is under assessment by the European Medicines Agency for patients with BRAFV600E-mutant advanced NSCLC. It was assessed in a Pfizer-sponsored clinical study, which was supported by Pierre Fabre.
Pierre Fabre medical and patient consumer department head Núria Perez-Cullell said: “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.”
Both in-vitro diagnostic assays have already received approval from the US Food and Drug Administration (FDA) for detecting targetable mutations, including BRAF, in blood and tissue-based solid tumour samples.
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By GlobalDataFoundation Medicine is said to have the only FDA-approved genomic profiling test portfolio, providing physicians with both blood and tissue-based testing choices to identify genomic alterations, such as BRAFV600E, to assist in personalised treatment decisions.
Foundation Medicine chief biopharma business officer Troy Schurr said: “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.”
