December 2019—The FDA approved Agilent Technologies’ PD-L1 IHC 22C3 pharmDx assay as an aid in identifying patients with esophageal squamous cell carcinoma for treatment with Keytruda (pembrolizumab), an anti-PD-1 therapy manufactured by Merck. Keytruda is approved for patients with recurrent locally advanced or metastatic ESCC whose tumors express PD-L1 (combined positive score ≥10), as determined by an FDA-approved test, with disease progression on or after one prior line of systemic therapy.
The assay also gained approval as an aid in identifying patients with head and neck squamous cell carcinoma for treatment with Keytruda. Keytruda as a single agent is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test.
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