On October 12, 2023 Foundation Medicine Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for Pfizer’s BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation (Press release, Pfizer, OCT 12, 2023, View Source [SID1234635912]).

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"We are thrilled to see both tests approved simultaneously for the same indication, which will expand access to this therapy option to more NSCLC patients who harbor a BRAF V600E mutation."

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Non-small cell lung cancer is the most common form of lung cancer, accounting for 80-85% of lung cancer diagnoses.1 BRAF V600E mutations occur in approximately 2% of NSCLC cases.2 BRAFTOVI and MEKTOVI are kinase inhibitors, which are a kind of targeted therapy that work by blocking enzymes and keeping cancer cells from growing.3 This therapy combination was previously approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

These companion diagnostic approvals mark the first simultaneous approval of both Foundation Medicine’s FDA approved tests as companion diagnostics for the same therapy. Both tests can help determine if BRAFTOVI in combination with MEKTOVI is an appropriate treatment option for certain patients. Foundation Medicine is the only company with an FDA-approved portfolio with tissue and blood-based comprehensive genomic profiling tests.

Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 30 companion diagnostic indications. From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across NSCLC, breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.

Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.

"Foundation Medicine’s FDA-approved companion diagnostic tests offer physicians a high-quality diagnostic tool to support their personalized treatment planning," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "We are thrilled to see both tests approved simultaneously for the same indication, which will expand access to this therapy option to more NSCLC patients who harbor a BRAF V600E mutation."

"We are grateful to see continued efforts to develop more treatment options for patients facing a non-small cell lung cancer diagnosis" said Danielle Hicks, Chief Patient Officer at GO2 for Lung Cancer. "It’s especially exciting to see that patients can be matched to this combination therapy from either a blood or tissue-based test, which expands avenues for more access to this treatment option."