US Food and Drug Administration's Directive to Deal With Delayed Confirmatory Trials: Lessons From Pralatrexate and Belinostat for T-Cell Lymphoma.

J Clin Oncol

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

Published: November 2024

AI Article Synopsis

  • The FDA is focusing on addressing the issue of delayed confirmatory trials, which are important for validating the effectiveness of cancer treatments.
  • The discussion highlights specific cases of pralatrexate and belinostat, two drugs used for treating T-cell lymphoma, to illustrate the challenges and lessons learned from these delays.
  • Insights from these examples aim to improve future clinical trial processes and ensure timely access to effective therapies for patients.

Article Abstract

The FDA's directive to deal with delayed confirmatory trials: lessons from pralatrexate and belinostat for T-cell lymphoma.

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http://dx.doi.org/10.1200/JCO.24.00100DOI Listing

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  • The discussion highlights specific cases of pralatrexate and belinostat, two drugs used for treating T-cell lymphoma, to illustrate the challenges and lessons learned from these delays.
  • Insights from these examples aim to improve future clinical trial processes and ensure timely access to effective therapies for patients.
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