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Navigating Tumor-Agnostic Drug Development: Value, Challenges and Strategic Insights for Sponsors

Article

What biopharma companies pursuing tumor-agnostic trials need to succeed when implementing launch models for these unique drug archetypes. 

The advent of molecularly guided therapy has led to innovative clinical trial designs that focus on genetic mutations rather than cancer type. These so-called tumor-agnostic trials test targeted therapies across various cancers with shared mutations and represent a change in approach from traditional indication-specific oncology drug development.  

There are currently seven tumor-agnostic FDA approvals for patients with advanced cancers. While the central focus of these approvals has been to provide patients access to novel therapies, these seven approvals fall into two archetypes that provide manufacturers with different values: target-focused and productivity-focused 

Fill out the form below to download the white paper and learn what companies pursuing a tumor-agnostic development path need to understand regarding the unique challenges and how to decide on the appropriate launch activities/commercial models aligning to these tumor-agnostic development archetypes. 


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