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  4. Measuring Toxicity in Reproductive Organs During Oncology Drug Development: An FDA - ASCO Virtual Workshop - 10/01/2024
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Workshop | Virtual

Event Title
Measuring Toxicity in Reproductive Organs During Oncology Drug Development: An FDA - ASCO Virtual Workshop
October 1 - 8, 2024

Date:
October 1 - 8, 2024
Day1:
Tue, Oct 01 1:00 p.m. - 05:00 p.m. ET
Day2:
Tue, Oct 08 9:00 a.m. - 12:15 p.m. ET

Twitter: #FDAASCOWkshp24

Background

Cancer survival has improved in recent decades, increasing the importance of studying the impact of anti-cancer treatments on quality of life such as on gonadal function and fertility. Incidence of cancer is also increasing in younger patients who are in their reproductive years. Many of these patients receive treatments that could produce reproductive toxicity. Damage to the gonads can lead to infertility, early menopause in women, and other adverse health consequences. At the same time, many clinical trials do not collect information on whether new treatments cause gonadal toxicity, creating an information gap for patients and their clinicians. In 2023, ASCO issued recommendations for assessing ovarian toxicity in cancer clinical trials. There is a need for additional education and guidance to inform the assessment of gonadal toxicity during oncology drug development. 

The FDA and American Society of Clinical Oncology (ASCO) have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of a workshop related to measuring gonadal toxicity during oncology drug development. Specific topics to discuss at this workshop could include: 

  • Highlighting patient voices and the importance of measuring gonadal toxicity during drug development to improve the quality of cancer care. 
  • Identifying nonclinical animal studies that support the measurement of gonadal toxicity. 
  • Evaluating the use of surrogate endpoints and biomarkers for measurement of gonadal toxicity in clinical trials. 
  • Exploring issues relevant to oncofertility, including fertility preservation options and pregnancy after cancer diagnosis and treatment

Meeting Goals

  • Provide a forum for open discussion among academia, industry, regulatory agencies, and patient groups about the importance of measuring gonadal toxicity and the patient perspective. 
  • Discuss how to apply nonclinical and clinical evaluations to measure gonadal toxicity during drug development. 
  • Discuss importance of oncofertility in the delivery of high-quality cancer care. 

Workshop Materials

Contacts

Caitlin Drew, MSN, RN
Senior Health Scientist 
Oncology Center of Excellence (OCE)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Caitlin.Drew@fda.hhs.gov

Nicole Holland 
Senior Program Coordinator, Research & Analysis 
Center for Research & Analytics (CENTRA)
American Society of Clinical Oncology
Nicole.Jenkins@asco.org

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