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Drug-biomarker co-development in oncology - 20 years and counting

Julianne D Twomey1, Nina N Brahme1, Baolin Zhang1

  • 1Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Drug Resistance Updates : Reviews and Commentaries in Antimicrobial and Anticancer Chemotherapy
|April 2, 2017
PubMed

Insights

Predictive biomarkers are crucial for identifying cancer patients who will respond to targeted therapies. Advancing these biomarkers requires understanding drug resistance and integrating multi-omics data for personalized cancer treatment.

Area of Science:

  • Oncology
  • Molecular Biology
  • Pharmacogenomics

Background:

  • Targeted cancer therapies require predictive biomarkers to identify responsive patient subsets.
  • Not all biomarker-positive patients respond to treatments, necessitating research into resistance mechanisms.
  • Current approaches often follow a "one marker, one drug" model, which may be insufficient.

Purpose of the Study:

  • To review the latest US Food and Drug Administration-approved biomarker-based cancer therapeutics.
  • To discuss the co-development of targeted therapeutics and predictive biomarkers.
  • To explore challenges and future directions in personalized oncology.

Main Methods:

  • Review of US Food and Drug Administration-approved oncology drugs and their associated predictive biomarkers.
  • Case studies analyzing targeted therapies for HER2, EGFR, and PD-1/PD-L1 pathways.
  • Discussion of integrated approaches including genomics, transcriptomics, and receptor status.

Main Results:

  • Highlights FDA-approved targeted therapies and their predictive biomarkers.
  • Illustrates successful targeting of HER2, EGFR, and PD-1/PD-L1 pathways.
  • Identifies the need for advanced biomarker strategies beyond single markers.

Conclusions:

  • Co-development of targeted therapeutics and predictive biomarkers is essential for effective cancer therapy.
  • Integrating multi-omics data and understanding resistance mechanisms will advance personalized oncology.
  • Future directions include moving beyond the "one marker, one drug" paradigm to novel therapeutic targets.
Keywords:
Co-developmentCompanion diagnosticsPredictive biomarkerTargeted cancer therapyTumor heterogeneity

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