Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx assay

Agilent Technologies (A) announced that the FDA has updated its approval of the company’s PD-L1 IHC 22C3 pharmDx assay. The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic non-small cell lung cancer, or NSCLC, for first-line treatment with KEYTRUDA, a targeted anti-PD-1 therapy manufactured by Merck (MRK). The FDA previously approved the assay to identify metastatic NSCLC patients whose tumors express PD-L1 Tumor Proportion Score of 50% or more for first-line treatment with KEYTRUDA. Now, patients with stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 TPS of 1% or more are eligible for first-line treatment. This expanded indication enables pathologists to identify a larger population of previously untreated patients who are now eligible for treatment with KEYTRUDA.

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