FDA expands approval of PD-L1 IHC 22C3 pharmDx assay in NSCLC

Agilent Technologies 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 (NSCLC) for first-line treatment with Keytruda, a targeted anti-PD-1 therapy manufactured by Merck & Co. (known as MSD outside the United States and Canada).

The FDA previously approved the assay to identify metastatic NSCLC patients whose tumors express PD-L1 Tumor Proportion Score (TPS) of at least 50% 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 at least 1% 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.

Agilent’s PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic that has been clinically validated and approved to identify NSCLC patients eligible for Keytruda.