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FINDING CURES TOGETHER<sup>SM</sup>

​FDA-AACR-SGO Regulatory Science and Policy Workshop 

FDA-AACR-SGO Drug Development in Gynecologic Malignancies Workshop

Date: June 14, 2018.

Read the agenda. Read the speaker bios. Access the workshop slides.
Read the guest blog post by Gwynn Ison, MD, Medical Officer, Division of Oncology Products 1, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.

Workshop videos: Session 1. Session 2. Session 3. Session 4.

Purpose

Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States, resulting in an unmet medical need. The ongoing revolution in oncology that has offered many new therapies to patients with a variety of cancer types has yet to reach these women. With the notable exception of the approvals of bevacizumab, and PARP inhibitors in ovarian cancer, we need to bring increased efforts to bear to spur the development of new treatment.

Goals and Objectives:

  • To provide a forum for open discussion between the FDA, clinicians, laboratory experts, and researchers on the way forward for diagnosis and treatment of gynecologic malignancies;
  • Accelerate the development of immunotherapy in gynecologic malignancies;Facilitate open discussions among all parties in the area of gynecologic malignancies;
  • Obtain input from multiple stakeholders on approaches to novel study designs to leverage rare subtypes in gynecologic malignancies; and
  • Discuss the impact of biomarkers in gynecologic malignancies.

Session I: Development of Immunotherapy in Gynecological Malignancies - Part 1

This session discusses the science behind why immunotherapy would work in GYN malignancies and biomarker issues associated with immunotherapy.

Session II: Development of Immunotherapy in Gynecological Malignancies - Part 2

This session discusses innovative study design ideas to examine contribution of effect of novel immunotherapy combinations in GYN malignancies.

Session III: Biomarker Development and PARP Inhibitors

Given the recent approvals of PARP inhibitors in the BRCA unselected patients, how can we better predict who will respond to these drugs since only a small percentage of BRCA negative group will do so? How can we identify that group?

Session IV: Development of Drugs for Rare Gynecological Malignancies

Development of drugs for rare GYN malignancy subset (e.g. clear cell ovarian cancer); this session will explore trouble with control arms, small sample sizes, need for more real world historic controls and single arm studies, vs. small cohorts within randomized trials.

Workshop Co-chairs:

  • FDA:
    • Sanjeeve Bala, MD, MPH, Clinical Team Leader Gynecologic Malignancies Group, Division of Oncology Products 1, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
    • Julia A. Beaver, MD, Director, Division of Oncology Products 1, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • AACR:
    • Deborah K. Armstrong, MD, Director, Breast and Ovarian Surveillance Service; Professor of Oncology; Professor of Gynecology & Obstetrics, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Gordon B. Mills, MD, PhD, Co-Director, Zayed Institute for Personalized Cancer Therapy, Department of Systems Biology 1, Division of Cancer Medicine, UT MD Anderson Cancer Center
  • Society of Gynecologic Oncology (SGO):
    • Rebecca Arend, MD, Assistant Professor of Obstetrics & Gynecology, University of Alabama at Birmingham
    • Robert L. Coleman, MD, FACOG, FACS, Vice Chair, Clinical Research, Department of Gynecologic Oncology and Reproductive Medicine, UT MD Anderson Cancer Center
    • Thomas Herzog, MD, Deputy Director & Professor of Obstetrics & Gynecology, University of Cincinnati Cancer Institute