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Biomarkers in oncology drug development: rescuers or troublemakers?

Estelle Marrer1, Frank Dieterle

  • 1Novartis Institutes for BioMedical Research, Translational Sciences, Novartis, Klybeckstr. 141, CH-4002 Basel, Switzerland. estelle.marrer@novartis.com

Expert Opinion on Drug Metabolism & Toxicology
|October 28, 2008
PubMed

Insights

Molecular biomarkers are crucial in oncology for targeted therapies and assessing treatment effectiveness. Despite significant investment, challenges remain in their clinical implementation for personalized medicine.

Area of Science:

  • Oncology
  • Molecular Biology
  • Pharmacology

Background:

  • Oncology pioneered the clinical use of molecular biomarkers.
  • Biomarkers are essential for novel targeted anticancer therapies and assessing efficacy/toxicity of cytotoxic treatments.
  • Biomarkers guide drug development from research to personalized medicine.

Purpose of the Study:

  • To critically review recent achievements in biomarker identification and development in oncology.
  • To explore the role of biomarkers in understanding drug mechanisms, monitoring targets, assessing efficacy/safety, and personalizing treatment.
  • To address the gap between pharmaceutical investment in biomarker development and their current clinical implementation.

Main Methods:

  • Literature review of recent advancements in biomarker identification and development.
  • Analysis of biomarker roles in drug development and personalized medicine.
  • Critical assessment of current challenges and future directions for biomarker implementation.

Main Results:

  • Biomarkers are integral to understanding drug action, target modulation, efficacy, safety, dosing, patient selection, and prognosis.
  • Despite substantial pharmaceutical investment, mandatory companion biomarker tests are limited for marketed oncology drugs.
  • The review highlights key achievements and ongoing challenges in translating biomarker research into clinical practice.

Conclusions:

  • Biomarker development is critical for achieving personalized oncology, ensuring the right treatment for the right patient.
  • Overcoming current implementation challenges is necessary to fully leverage biomarker potential in cancer care.
  • Continued investment and strategic development are essential for advancing biomarker-guided oncology.

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