• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

  • Print
  • Share
  • E-mail
-

Search Publications



Fields



Centers











Starting Date


Ending Date


Order by

Entry Details

Clin Cancer Res 2019 Dec 23 [Epub ahead of print]

Progress and opportunities to advance clinical cancer therapeutics using tumor dynamic models.

Bruno R, Bottino D, de Alwis DP, Fojo AT, Guedj J, Liu C, Swanson KR, Zheng J, Zheng Y, Jin JY

Abstract

There is a need for new approaches and endpoints in oncology drug development, particularly with the advent of immunotherapies and the multiple drug combinations under investigation. Tumor dynamics modeling, a key component to oncology 'model-informed drug development', has shown a growing number of applications and a broader adoption by drug developers and regulatory agencies in the past years to support drug development and approval in a variety of ways. Tumor dynamics modeling in also being investigated in personalized cancer therapy approaches. These models and applications are reviewed and discussed as well as the limitations and issues open for further investigations. A close collaboration between stakeholders like clinical investigators, statisticians and pharmacometricians is warranted to advance clinical cancer therapeutics.


Category: Journal Article
PubMed ID: #31871299 DOI: 10.1158/1078-0432.CCR-19-0287
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2019-12-29
Feedback
-
-