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Regulatory considerations on endpoints in ovarian cancer drug development

Sanjeeve Balasubramaniam1, Geoffrey S Kim1, Amy E McKee1

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

Cancer
|May 13, 2017
PubMed

Insights

Advanced ovarian cancer treatments are improving due to faster drug development and regulatory flexibility. This allows for new therapies like targeted treatments and immunotherapies to reach patients sooner.

Area of Science:

  • Oncology
  • Clinical Pharmacology

Background:

  • Ovarian cancer significantly contributes to global female morbidity and mortality.
  • Recent advancements in drug research and development offer new treatment options for advanced ovarian cancer.
  • Accelerated approval of two agents signals a shift towards faster therapeutic interventions.

Purpose of the Study:

  • To discuss the impact of modern drug research and accelerated development timelines on advanced ovarian cancer treatment.
  • To explore the role of regulatory flexibility in expediting the approval of novel therapies.
  • To highlight the potential of intermediate endpoints in clinical trial design for new therapeutic classes.

Main Methods:

  • Review of current trends in drug development for ovarian cancer.
  • Analysis of regulatory pathways and their impact on treatment accessibility.
  • Discussion of emerging therapeutic strategies, including targeted therapies and immunotherapies.

Main Results:

  • Accelerated approval of two agents for advanced ovarian cancer indicates progress.
  • A growing number of registrational trials are underway for new ovarian cancer treatments.
  • Regulatory flexibility is crucial for addressing serious and life-threatening conditions.

Conclusions:

  • Modern drug development is enhancing treatment options for advanced ovarian cancer.
  • Regulatory flexibility supports the timely introduction of innovative therapies.
  • Intermediate endpoints can facilitate the development of targeted therapies and immunotherapies for ovarian cancer.
Keywords:
US Food and Drug Administration (FDA)bevacizumabdrug approvaldrug developmentdrug regulationolaparibovarian cancer

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