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Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug

Elizabeth S Duke1, Michael J Fusco1, Patrick DeMoss1

  • 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Cancer Discovery
|December 2, 2022
PubMed

Insights

Cancer drug development advanced in 2022, focusing on rare diseases and personalized medicine. Some accelerated approvals were confirmed, while others were withdrawn due to unverified clinical benefit.

Area of Science:

  • Oncology
  • Pharmacology
  • Drug Development

Background:

  • Cancer drug development shows resilience despite the COVID-19 pandemic.
  • The year 2022 saw significant advancements in oncology drug approvals.

Purpose of the Study:

  • To summarize key highlights of U.S. oncology drug approvals in 2022.
  • To review trends in cancer drug development, including rare diseases and accelerated approvals.

Main Methods:

  • Review of U.S. Food and Drug Administration (FDA) oncology drug approvals for 2022.
  • Analysis of trends in drug development, dosage optimization, and post-approval study outcomes.

Main Results:

  • Continued progress in developing drugs for rare diseases and specific molecular subgroups.
  • Improved dosage optimization strategies were noted.
  • Confirmatory studies verified clinical benefit for some accelerated approvals.
  • Indication withdrawals occurred when clinical benefit was not verified.

Conclusions:

  • Cancer drug development remains dynamic, adapting to challenges like the pandemic.
  • Regulatory pathways, including accelerated approval and confirmatory studies, play a crucial role in bringing effective cancer therapies to patients.

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