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

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.