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Agilent's Keytruda CDx Granted Expanded CE Mark

NEW YORK (GenomeWeb) – Agilent Technologies announced Tuesday that the European Commission had granted expanded use in Europe for its Dako PD-L1 IHC 22C3 pharmDx, a companion diagnostic for Merck's Keytruda (pembrolizumab).

The CE-marked test can now be used for patients with metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK mutations who have not yet been treated. The European Commission has also approved Keytruda for first-line treatment of those patients, in addition to its previous indication in patients who have already undergone chemotherapy.

"Keytruda data continues to demonstrate the important role of PD-L1 testing in the treatment of patients with non-small cell lung cancer in order to identify those patients most likely to respond to treatment," Merck Senior VP Roger Dansey said in a statement. "The expansion of the companion diagnostic's approval to include first-line evaluation means European oncologists have the ability to help even more patients with lung cancer."

The expanded approval in Europe mirrors the US Food and Drug Administration's recent approval of the anti-PD-1 humanized antibody as a first-line treatment for NSCLC, and with it, the use of the Dako companion diagnostic.

Agilent noted that the diagnostic is the only assay currently available which can select NSCLC patients who may benefit from first-line treatment with Keytruda or any other anti-PD-1 therapy. However, NanoString Technologies has been collaborating with Merck on developing a gene expression-based companion diagnostic for Keytruda.


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