MRK - Agilent gastric cancer assay wins FDA nod

2023-11-14 08:52:33 ET

The U.S. FDA has approved Agilent's ( NYSE: A ) PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who may be eligible for Merck's ( MRK ) Keytruda (pembrolizumab) treatment.

Patients with gastric or GEJ cancer whose tumors express PD-L1 pathway can now be identified for potential treatment with Keytruda using PD-L1 IHC 22C3 pharmDx.

Agilent ( A ) developed this assay in partnership with Merck ( MRK ) as a companion diagnostic for Keytruda. This marks the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval.

Lou Welebob, vice president and general manager of Agilent’s Pathology Division, stated, "PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as Keytruda. This endorsement underscores Agilent's leadership in the development of companion diagnostics for groundbreaking anti-PD-1 therapies."

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