FDA-ASCO-Friends Workshop on Development of Tissue-Agnostic, Biomarker-Based Indications
Co-Sponsored by the:
U.S. Food & Drug Administration (FDA), American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends)
Twitter: #FDATissueAgnostic19
Date: April 26, 2019
Time: 8:30 am to 4:00 pm
Location: FDA White Oak Campus
Building 31, Room 1503 - Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Background:
The FDA, ASCO and Friends are convening this public workshop to identify clinical trial designs and strategies to accelerate drug development based on biomarkers that are agnostic to tissue types. The workshop is intended to explore concepts in research and development that would assist the research community and regulators in understanding how to optimize product development and patient access to safe and effective biomarker-driven therapies that have clinical use across a variety of cancer types.
Workshop Objectives:
- Seek feedback from industry, academia, patients and other stakeholders on trial designs and analysis approaches that will aid in understanding the effect of a biomarker and its related diagnostic assay across multiple tissue types,
- Ensure that cancer patient advocates and the leading experts in clinical research, pharmacology, drug manufacturing, and clinical care have an opportunity to contribute to the discussion about how to demonstrate safety and efficacy of a drug across multiple cancer types and how to communicate that information to the clinical community, and
- Obtain input from multiple stakeholders on approaches the FDA uses to review applications for drug products that are intended to treat cancers based on the presence of a biomarker, rather than specification of the tissue type.
Webcast Information:
FDA provided a free-of-charge, live webcast of this workshop. Recordings of the webcast can be found at the following links:
- Part 1: https://collaboration.fda.gov/pjxt45w7e1qg/
- Part 2: https://collaboration.fda.gov/p3ax6ttx47qz/
- Part 3: https://collaboration.fda.gov/pow99hvv7wcb/
- Part 4: https://collaboration.fda.gov/psbtqhe4p9d6/
Meeting Information:
- Final Agenda (PDF- 86KB)
- Questions for Multi-Stakeholder Panels (PDF - 104KB)
- Panelist and Speaker Biosketches (PDF - 153KB)
- Slides
- Complexities/Key Lessons Learned from Case Examples
- KEYTRUDA (pembrolizumab) Case Study. (PDF - 1190KB)
- Eric Rubin, MD (Merck Research Laboratories) - The Tissue-Agnostic Development of Larotrectinib / Vitrakvi (PDF - 1244KB)
- Josh Bilenker, MD (Loxo Oncology)
- KEYTRUDA (pembrolizumab) Case Study. (PDF - 1190KB)
- Complexities/Key Lessons Learned from Case Examples
Contact:
If to ASCO:
Anna Jinkerson, MScM
Anna.Jinkerson@asco.org
(571) 483-1577
If to FDA:
Sonia Swayze
Sonia.Swayze@fda.hhs.gov
(301) 796-6132
Dianne Spillman
Dianne.Spillman@fda.hhs.gov
(301) 796-1467
If to Friends:
Ryan Hohman, JD
rhohman@focr.org
(202) 944-6708
Mark Stewart, PhD
mstewart@focr.org
(202) 944-6700