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Updated: Jul 26, 2025

Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
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Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy

Ruby Leong1, Manuela Grimstein1, Peter DeMaria2

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Journal of Clinical Pharmacology
|June 15, 2023
PubMed

Insights

Managing cancer in pregnant women with targeted therapies is challenging due to limited data. Physiologically based pharmacokinetic modeling can help optimize drug dosing for this population.

Area of Science:

  • Oncology
  • Pharmacology
  • Maternal-Fetal Medicine

Background:

  • Cancer occurs during pregnancy, affecting various types like breast, melanoma, and leukemia.
  • Managing cancer in pregnant women with molecularly targeted oncology drugs presents significant challenges.
  • Knowledge gaps exist regarding the safety, efficacy, and optimal dosing of these drugs in pregnancy.

Purpose of the Study:

  • To address the challenges in managing cancer during pregnancy with molecularly targeted oncology drugs.
  • To improve understanding of drug pharmacokinetics altered by pregnancy and cancer.
  • To inform dosing recommendations and facilitate future clinical studies for pregnant cancer patients.

Main Methods:

  • Utilizing physiologically based pharmacokinetic (PBPK) modeling.
  • Incorporating physiological changes induced by both cancer and pregnancy.
  • Analyzing alterations in drug absorption, distribution, metabolism, and excretion.

Main Results:

  • PBPK modeling has the potential to inform dosing strategies for pregnant women with cancer.
  • It can enhance understanding of pregnancy-related pharmacokinetic changes in cancer patients.
  • Facilitates the design of studies to support dosing recommendations and regulatory decisions.

Conclusions:

  • Physiologically based pharmacokinetic modeling is a valuable tool for optimizing molecularly targeted oncology drug use in pregnant women.
  • This approach can bridge knowledge gaps and improve patient care.
  • Model-informed data supports regulatory decision-making for drug approvals in this population.
Keywords:
Clinical Pharmacology (CPH)Oncology (ONC)PBPKSpecial PopulationsWomen's Health

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