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Related Concept Videos

Tumor Immunotherapy01:27

Tumor Immunotherapy

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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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Seven tumor-agnostic drug approvals have occurred since 2017. This paper summarizes their development, regulatory pathways, and offers insights for future precision medicine drug development.

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Area of Science:

  • Oncology
  • Pharmacology
  • Regulatory Science

Background:

  • The FDA approved the first tumor-agnostic indication in 2017.
  • Six drugs have received seven tumor-agnostic approvals to date.
  • Tumor-agnostic therapies target specific molecular alterations irrespective of tumor origin.

Purpose of the Study:

  • To provide a comprehensive summary of FDA-approved tumor-agnostic indications.
  • To detail mechanisms of action, biomarker prevalence, study designs, and companion diagnostics.
  • To discuss regulatory and health technology assessment aspects, including global comparisons.

Main Methods:

  • Review of seven FDA-approved tumor-agnostic indications.
  • Analysis of study designs, biomarker strategies, and regulatory submissions.
  • Examination of health technology assessment and global regulatory landscapes.

Main Results:

  • Summary of six drugs with seven tumor-agnostic approvals since 2017.
  • Detailed review of mechanisms, biomarkers, study designs, and companion diagnostics.
  • Comparative analysis of global regulatory requirements and HTA approvals.

Conclusions:

  • Practical considerations for designing and developing tumor-agnostic therapies are presented.
  • Recommendations are provided to mitigate risks during the design phase.
  • Strategies for post-approval drug development, including confirmatory basket trials, are discussed.