FoundationOne CDx is Now FDA Approved as a Diagnostic Tool For ALK+ Non-Small Cell Lung Cancer

FoundationOne CDx is a comprehensive genomic profiling test that is tissue based. It is used to identify individuals diagnosed with ALK+ non-small-cell lung cancer (NSCLC) who will be eligible for brigatinib treatment.

FoundationOne CDx has just been FDA approved as a test for detecting solid tumors in this patient population. It will be a companion diagnostic used with brigatinib.

The technology is able to detect deletions, insertions, substitutions, and alterations in 324 different genes and gene rearrangements, as well as genomic signatures. It can profile the tumor mutation and detect ALK positivity. Although this test is not perfect, its a huge step forward for research in this field.

The Approvals 

Brigatinib was first approved in May 2020 as a first-line treatment following a Phase 3 trial called ALTA-1L. In this investigation, brigatinib was shown to reduce the risk of disease progression and death by 76% in patients who had recently been diagnosed. Patients in this trial did not have brain metastases.

This therapy is a TKI and it specifically targets ALK molecular alterations.

There were 275 participants given brigatinib. They received 90mg of the treatment each day by mouth for one week. After the first seven days the treatment was increased and patients received 180mg each day. These individuals had a median progression-free survival of 24 months. There was an overall response rate of 74%.

The second group of patients (138 individuals) were given crizotinib. They were given 250mg of the treatment two times every day. This group had a progression-free survival of just 11 months. For these patients, there was an overall response rate of 62%.

Some common adverse events with brigatinib treatment were cough, rash, nausea, fatigue, and diarrhea. These occurred a quarter of the time for patients.

The new approval of FoundationOne Cdx reinforces how important genomic profiling is. It further demonstrates how valuable this can be for diagnosing and making treatment decisions for this patient population.


1. FoundationOne®CDx receives FDA-approval as a companion diagnostic for ALUNBRIG® (brigatinib) to identify patients with ALK positive metastatic non-small cell lung cancer. News Release. Foundation Medicine. July 1, 2021. Accessed July 6, 2021.

2. FDA approves brigatinib for ALK-positive metastatic NSCLC. News Release. FDA. May 26, 2020. Accessed July 6, 2021.

You can read more about this recent approval here.

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