First Complementary Diagnostic Approved to Support Use of OPDIVO for Non-Squamous Non-Small Cell Lung Cancer

Strategic Insights -

The U.S. Food and Drug Administration has approved a new test that can identify PD-L1 expression levels on the surface of non-small cell lung cancer tumor cells and provide information on the survival benefit with OPDIVO (nivolumab) for patients with non-squamous NSCLC. This approval marks a significant milestone in the field of cancer diagnostics and therapy, as it provides a crucial tool for healthcare providers to determine the most effective treatment options for patients with this type of cancer.

Key Takeaways:

  • The FDA has approved the first complementary diagnostic, PD-L1 IHC 28-8 pharmDx, to support the use of OPDIVO (nivolumab) for non-squamous non-small cell lung cancer (NSCLC).
  • The diagnostic was developed through a collaboration between Dako, an Agilent Technologies company, and Bristol-Myers Squibb, the maker of OPDIVO (nivolumab).
  • The diagnostic was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO (nivolumab) demonstrated superior overall survival in patients with previously treated metastatic non-squamous NSCLC compared to chemotherapy.
  • The FDA has expanded the indication for OPDIVO (nivolumab) to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication.
  • Lung cancer is the leading cause of cancer-related deaths worldwide, and historically, the one-year overall survival in the second-line treatment of NSCLC has been about 26 percent.
  • The approval of PD-L1 IHC 28-8 pharmDx highlights the importance of immunohistochemical-based diagnostics in cancer therapy and underscores the potential of PD-L1 as a biomarker for predicting the effectiveness of OPDIVO (nivolumab) in treating NSCLC.
  • Dako is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy, and the approval of PD-L1 IHC 28-8 pharmDx marks an important milestone in this partnership.

Statistics:

  • 26%: Historically, the one-year overall survival in the second-line treatment of non-small cell lung cancer (NSCLC)
  • 100: Number of countries where Dako operates
  • 12,000: Number of employees worldwide at Agilent Technologies, the parent company of Dako
  • $4.0 billion: Revenues generated by Agilent Technologies in fiscal 2014
  • 2012: Year in which Agilent acquired Dako, a well-known provider of reagents, instruments, software, and expertise to make accurate diagnoses and determine the most effective treatment for cancer patients

Sources:

  • Dako Denmark A/S via Globenewswire
  • Thomson Reuters ONE via COMTEX
  • Agilent Technologies website (www.agilent.com)
  • Dako website (www.dako.com)