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Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology

Jan Trøst Jørgensen1, Maria Hersom2

  • 1Dx-Rx Institute, Fredensborg, Denmark.

Clinical Pharmacology and Therapeutics
|December 3, 2017
PubMed

Insights

Companion diagnostics, essential for safe anticancer drug use, have governed 21 therapies since FDA approval nearly 20 years ago. These assays are vital in drug development and treatment decisions.

Area of Science:

  • Oncology
  • Medical Diagnostics
  • Pharmacogenomics

Background:

  • The US Food and Drug Administration (FDA) approved the first companion diagnostic assay nearly two decades ago.
  • Companion diagnostics are now integral to the use of 21 distinct anticancer drugs.
  • Regulatory bodies mandate these assays for ensuring the safe and effective application of specific therapeutic products.

Purpose of the Study:

  • To highlight the significance of companion diagnostics in oncology.
  • To underscore their role throughout the drug lifecycle, from development to clinical practice.

Main Methods:

  • Review of FDA approvals and regulatory guidance on companion diagnostics.
  • Analysis of the impact of companion diagnostics on anticancer drug utilization.

Main Results:

  • Companion diagnostics have been available for approximately 20 years.
  • Currently, 21 anticancer drugs require companion diagnostics for their use.
  • These assays are critical for both drug development and patient treatment decisions.

Conclusions:

  • Companion diagnostics are indispensable tools in modern oncology.
  • Their role is crucial for personalized medicine and optimizing cancer treatment outcomes.
  • The continued development and implementation of companion diagnostics are essential for advancing cancer care.

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