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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 expanded approval for the assay as a CDx for the drug for gastric or gastroesophageal junction adenocarcinoma, and followed that with an approval for use in cervical cancer patients this past June.

The diagnostic was also granted CE marking in August 2016 as a CDx for Keytruda for patients with previously treated, advanced non-small cell lung cancer with PD-L1 expressing tumors. In January 2017, the CE marking for the CDx was expanded to include patients with metastatic NSCLC with no EGFR or ALK mutations who had not yet been treated. And this August, the CE marking expanded to include urothelial carcinoma.

"Anti-PD-1 therapies are a promising treatment class for many cancer types, and early PD-L1 testing can provide critical information to physicians managing urothelial carcinoma patients," Sam Raha, president of Agilent's diagnostics and genomics group, said in a statement. "By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need for treatment options in patients who are ineligible for cisplatin-containing chemotherapy."

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