On May 3, 2023 Foundation Medicine, Inc., a leader in molecular profiling for cancer, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for EXKIVITY (mobocertinib), which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Foundation Medicine, MAY 3, 2023, View Source [SID1234630953]). For full Indication, Important Safety Information and link to the Prescribing Information, please see ‘About Exkivity’ below. FoundationOne Liquid CDx is the only blood-based comprehensive genomic profiling (CGP) test that is FDA-approved to detect EGFR exon 20 insertion mutations to identify patients who may be appropriate for treatment with EXKIVITY.

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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 Approximately 1-2% of patients with NSCLC have EGFR exon 20 insertion mutations, which are more common in Asian populations compared to Western populations.2-6

"EGFR exon 20 insertion-positive NSCLC is a rare and historically underdiagnosed disease that requires a targeted treatment approach at the molecular level due to its unique mutation," said Stefanie Granado, head, U.S. Oncology Business Unit, Takeda. "The approval of this indication for Foundation Medicine’s blood-based companion diagnostic test is another important step forward to expand the identification of patients in the U.S. with this rare cancer and improve access for people who may benefit from treatment with EXKIVITY, including those unable to undergo tumor biopsy."

Foundation Medicine’s two FDA-approved tests meet rigorous analytical and clinical validation standards. From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes for genomic alterations that cause cancer to grow.

"Cancer is an incredibly complex disease, so it’s critical that oncologists leverage companion diagnostics, which are high-quality, well-validated genomic tests, to inform treatment decisions for their patients," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "We’re proud of the work we’ve done with Takeda to develop blood and tissue-based companion diagnostics for therapies in their precision oncology pipeline, including this recent approval for EXKIVITY."

"People living with rare forms of lung cancer like EGFR exon 20 insertion mutated NSCLC often face limited treatment options," said Danielle Hicks, chief patient officer at GO2 for Lung Cancer. "It’s encouraging to see continued progress toward improving access to new treatment options for patients living with advanced non-small cell lung cancer."