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FoundationOne Liquid Biopsy Assay Gets FDA OK as Companion Diagnostic for Takeda's Exkivity

NEW YORK – Foundation Medicine said Thursday that the US Food and Drug Administration has approved its FoundationOne Liquid CDx assay as a companion diagnostic for Takeda's Exkivity (mobocertinib).

The drug is FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer who test positive for EGFR exon 20 insertion mutations via an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.

The approval makes FoundationOne Liquid CDx — a blood-based DNA sequencing assay that targets alterations in 324 genes —the only blood-based comprehensive genomic profiling test currently indicated for identifying these patients.

Foundation said that approximately 1 percent to 2 percent of patients with NSCLC have EGFR exon 20 insertion mutations, which are more common in Asian populations compared to Western populations.

"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 of Takeda's US oncology business unit. "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 US with this rare cancer and improve access for people who may benefit from treatment … including those unable to undergo tumor biopsy."

FoundationOne Liquid CDx has now received FDA approval for use with a variety of therapies across a range of solid tumors.