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Establishment and Characterization of Patient-Derived Xenograft Models of Anaplastic Thyroid Carcinoma and Head and Neck Squamous Cell Carcinoma

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Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model.

Ágnes Benedict¹, Gábor Szabó², Kinga Marczell²

¹Evidera/PPD, Vienna, Austria.

Journal of the National Comprehensive Cancer Network : JNCCN

|April 22, 2024

Summary

The FDA Accelerated Approval Program (AAP) for cancer therapies has provided an estimated 263,000 life years for patients in the U.S. This study quantifies the population-level survival benefit of AAP-approved oncology drugs.

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Area of Science:

Oncology
Health Economics
Regulatory Science

Background:

The FDA Accelerated Approval Program (AAP) has faced scrutiny regarding its population-level health benefits.
Quantifying the impact of AAP on patient survival in oncology has been lacking.

Purpose of the Study:

To estimate the life years gained by cancer patients due to therapies approved via the FDA's Accelerated Approval Program (AAP) in the U.S. between 2006 and 2022.

Main Methods:

Utilized FDA data, clinical trial results, and uptake tools to identify 130 oncology treatments approved under AAP.
Developed a decision analytic model to estimate survival gains and accumulate life years for patient cohorts.
Calculated incremental life years gained attributable to the AAP by comparing with and without AAP scenarios.

Main Results:

An estimated 263,000 life years were gained by approximately 911,000 cancer patients through December 2022 in the U.S.
This benefit is associated with 69 products approved under the AAP for which overall survival data were available.

Conclusions:

The AAP has delivered a substantial survival benefit, measured in life years gained, for cancer patients, particularly those with high unmet needs.
Assessing the impact on patient survival is crucial for policy discussions surrounding the evaluation of the AAP.