2021-07-04| Trials & Approvals

FoundationOne CDx Okayed as Companion Diagnostic for Takeda’s Lung Cancer Drug

by Rajaneesh K. Gopinath
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On July 1st, Foundation Medicine announced receiving yet another FDA approval for its comprehensive genomic profiling (CGP) test. The Roche subsidiary’s FoundationOne CDx was approved to be used as a companion diagnostic for Takeda’s Lung cancer drug, Alunbrig.

Alunbrig (brigatinib) is a next-generation tyrosine kinase inhibitor designed to target and inhibit anaplastic lymphoma kinase (ALK) genetic alterations. After notching the accelerated approval in 2017, the once-daily oral therapy was FDA approved in May 2020 as a first-line treatment for adult patients with ALK-positive metastatic non-small cell lung cancer (mNSCLC).

“This approval reinforces the importance of comprehensive genomic profiling in patient care and confirms its value in guiding treatment decisions at diagnosis of metastatic non-small cell lung cancer,” said Brian Alexander, M.D., M.P.H., CEO at Foundation Medicine. “We’re proud to partner with Takeda to ensure patients with this serious condition have access to this important treatment option.”


Yet Another FDA Approval for FoundationOne CDx

FoundationOne CDx is an in vitro diagnostic device that uses next-generation sequencing to detect genetic alterations. It spots substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and gene rearrangements as well as genomic signatures, including microsatellite instability (MSI) and tumor mutational burden (TMB).

FoundationOne CDx is the first FDA-approved tissue-based CGP test that is clinically and analytically validated for solid tumors. In March 2018, it also became the first FDA-approved broad companion diagnostic with Medicare coverage. The assay, which now has 28 companion diagnostic claims, can now detect ALK-positive mNSCLC patients who may be appropriate to receive Alunbrig as a first-line or later-line therapy.

The approval is a culmination of a collaboration agreement signed in September 2020 between Foundation Medicine and Takeda to develop companion diagnostics for the latter’s late-stage lung cancer portfolio.

“We are excited by the approval of FoundationOne CDx as a companion diagnostic for ALUNBRIG, an important milestone in the diagnosis and treatment of people living with ALK+ non-small cell lung cancer,” said Dion Warren, head, U.S. Oncology Business Unit, Takeda.

“The approval of FoundationOne CDx to inform treatment with ALUNBRIG is the first of three companion diagnostics in development as part of our ongoing partnership between Foundation Medicine and Takeda aimed at addressing the urgent need for broad access to genomic tests and expanding treatment options for people with lung cancer.”

Related Article: FDA Okays Second FGFR Inhibitor for Cholangiocarcinoma, Approves FMI’s CGP Test as Companion Diagnostic


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