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Ag(e)nostic precision oncology therapy approvals across the years

Matthew R Kudek1, Jacob J Adashek2, Razelle Kurzrock3

  • 1Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA; Department of Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI, USA.

Trends in Cancer
|June 6, 2025
PubMed

Insights

Precision oncology treatments targeting molecular aberrations are evolving. Tumor-agnostic and age-agnostic therapies should become standard for cancer treatment, especially for rare cancers.

Area of Science:

  • Oncology
  • Genetics
  • Pharmacology

Background:

  • Precision oncology initially required tumor-specific biomarkers for targeted therapies.
  • Rare cancers, including pediatric cancers, face challenges in clinical trial enrollment due to infrequent biomarkers.

Purpose of the Study:

  • To provide historical context for precision oncology.
  • To advocate for age- and tumor-agnostic precision oncology approvals as the standard.

Main Methods:

  • Literature review and historical analysis of precision oncology drug approvals.
  • Analysis of regulatory trends and clinical trial enrollment barriers.

Main Results:

  • Tumor-agnostic therapies have been approved, addressing unmet needs in rare and pediatric cancers.
  • Age-agnostic precision oncology therapies are also emerging, applicable across all age groups.

Conclusions:

  • The approval of highly active biomarker-based, tumor-agnostic therapies is critical for rare cancer populations.
  • Age- and tumor-agnostic precision oncology approvals should be the standard, not the exception, for future therapeutics.
Keywords:
ag(e)nosticprecision therapy

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