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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

 

References

  1. Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC. Agilent Therapeutics. Published April 16, 2019. https://bit.ly/2PnPAK5. Accessed April 17, 2019.
  2. FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%). FDA. Published April 11, 2019. https://bit.ly/2Ut6Cfv. 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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