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FDA Expands Approval of PD-L1 IHC 22C3 pharmDX Assay in NSCLC

Gina Columbus @ginacolumbusonc
Published: Wednesday, Apr 17, 2019

Sam Raha

Sam Raha

The FDA has expanded the approval of the PD-L1 IHC 22C3 pharmDX assay, allowing the test to be used as a companion diagnostic to identify more patients with stage III or metastatic non–small cell lung cancer (NSCLC) who can undergo first-line treatment with pembrolizumab (Keytruda).1



  1. Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC. Agilent Therapeutics. Published April 16, 2019. Accessed April 17, 2019.
  2. FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%). FDA. Published April 11, 2019. Accessed April 11, 2019.
  3. Lopes G, Wu YL, Kudaba I, et al. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: open-label, phase 3 KEYNOTE-042 study. Presented at: 2018 ASCO Annual Meeting; June 1-5; Chicago. Abstract LBA4.

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