FDA Approves Expanded Use of Agilent Assay as Keytruda CDx for Urothelial Cancer

NEW YORK (GenomeWeb) – Agilent Technologies announced today that the US Food and Drug Administration has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use as a companion diagnostic test for Merck’s anti-PD1 immunotherapy Keytruda (pembrolizumab) for urothelial carcinoma.

The test can now be used by physicians to identify patients with cancer of the urinary system who may benefit from Keytruda as a first-line treatment option. Keytruda is approved for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to identify patients with urothelial carcinoma for treatment with Keytruda, Agilent said.

The two companies developed the Dako assay in partnership, and the FDA initially approved it as a companion diagnostic for Keytruda for non-small cell lung cancer in October 2015. A year later, the agency granted expanded approval for the assay as a CDx for Keytruda to determine expression status and inform treatment in a broader range of metastatic NSCLC patients. In September 2017, the FDA

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