Stephan Emmerth

Stephan Emmerth

PhD | Director Therapeutic Innovation and BaseLaunch

Tel. +41 61 295 50 17

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(img: Roche)

(img: Roche)


Roche granted approval for lung cancer test

The US Food and Drug Administration (FDA) has approved a Roche diagnostic procedure capable of detecting a specific biomarker in lung cancer patients. If present, patients are then eligible for treatment with a Novartis drug.

Roche announced that its VENTANA ALK (D5F3) CDx Assay has received approval by the FDA. The companion diagnostic is capable of detecting the ALK (anaplastic lymphoma kinase) biomarker found in non-small cell lung cancer (NSCLC). ALK-positive NSCLC patients are eligible for treatment with the Novartis drug Zykadia.

Last week, Novartis received FDA approval for expanded use of Zykadia in the first-line of treatments with metastatic NSCLC.

VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Zykadia.

“With the FDA's approval of the expanded use of the VENTANA ALK (D5F3) CDx Assay to determine which lung cancer patients are eligible for Zykadia, we are helping clinicians and their patients identify additional treatment options for non-small cell lung cancer,” said Ann Costello, Head of Roche Tissue Diagnostics.


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