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FDA Approves FoundationOne CDx for Takeda's ALK-Inhibitor

NEW YORK – Foundation Medicine said on Thursday that the US Food and Drug Administration has approved the company's tissue-based, next-generation sequencing test, FoundationOne CDx, as a companion diagnostic for Takeda's FDA-approved non-small cell lung cancer treatment brigatinib (Alunbrig).

The approval comes after Roche subsidiary Foundation Medicine and Takeda inked a deal last year to develop companion diagnostics for Takeda's NSCLC agents. Brigatinib has been FDA-approved to treat ALK-positive NSCLC patients who are refractory to crizotinib (Pfizer's Xalkori) since 2017, and it is approved as a first-line treatment for ALK-positive NSCLC since last year. At the time of brigatinib's first-line FDA approval, the agency approved Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic.

FDA's decision to approve FoundationOne CDx as a companion diagnostic for brigatinib, according to Foundation Medicine, reflects a recognition that ALK rearrangements can be overlooked with alternative non-NGS testing methods. FoundationOne CDx, which detects substitutions, insertion and deletion alterations, copy number alterations in 324 genes, and select gene rearrangements, now has a total of 28 companion diagnostic claims.

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