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.
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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Foundation 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.”