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Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug

Joshua M Donaldson1, Marjilla Seddiq1, Michael J Fusco1

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

Cancer Discovery
|December 12, 2023
PubMed
Abstract

Insights

Cancer drug development saw significant advancements in 2023, with new immunotherapies and targeted treatments approved. These breakthroughs offer novel options for adult, pediatric, and rare disease cancer patients.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Cancer drug development is a dynamic field.
  • Continuous innovation is crucial for patient outcomes.

Purpose of the Study:

  • To summarize key U.S. drug approvals in cancer therapy for 2023.
  • To highlight advancements in immunotherapies and targeted drug development.

Main Methods:

  • Review of U.S. Food and Drug Administration (FDA) drug approvals in 2023.
  • Categorization of approved drugs by therapeutic class and patient population.

Main Results:

  • Robust activity in cancer drug development observed in 2023.
  • Approval of novel immunotherapies and targeted therapies.
  • Expansion of treatment options for adult, pediatric, and rare disease populations.

Conclusions:

  • 2023 marked a strong year for cancer therapeutic approvals.
  • New treatments underscore progress in personalized medicine and immunotherapy.
  • Continued development is vital for addressing diverse oncological needs.

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