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Impact of an evolving regulatory landscape on skin cancer drug development in the U.S.

  • Author(s): Miller, David M;
  • Shalhout, Sophia Z;
  • Casey, Denise;
  • Fashoyin-Aje, Lola;
  • Lemery, Steven;
  • Theoret, Marc R;
  • Pazdur, Richard
  • et al.
Abstract

Background: There has been a rapid proliferation of FDA-approved medications with labeled indications for skin cancer over the last decade, with particular growth over the last 5 years. Objective: We aimed to evaluate the impact of an evolving U.S. regulatory framework on drug development programs to better understand current trends and regulatory considerations when adjudicating drug approvals for patients with skin cancer. Methods: We reviewed publicly-available regulatory documents of all systemic medications with a labeled indication for skin cancer. Results: We identified 130 FDA approvals that resulted in a unique indication, usage, formulation, or dosage change in skin cancer since 1949. Limitations: Publicly available data from the mid-to-late 20th century is limited. Conclusions: The therapeutic landscape in skin cancer has changed greatly since the first approval in 1949. In concert, regulatory medicine has also evolved over the last 70 years with the aim of ensuring safe and effective medicines for a diverse array of patients.

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