Co-Sponsored by the:
U.S. Food & Drug Administration (FDA) and
the National Brain Tumor Society (NBTS)

In collaboration with:
Accelerate Brain Cancer Cure (ABC2); American Brain Tumor Association (ABTA);
Friends of Cancer Research (Friends); Kidney Cancer Research Alliance (KCCure);
LUNGevity Foundation; Melanoma Research Alliance (MRA);
Metastatic Breast Cancer Alliance (MBC Alliance)
RANO (Response Assessment in Neuro-Oncology)
and Society for NeuroOncology (SNO)

Twitter: #MetsCNS2019 #CNSMetsWorkshop2019

Date: March 22, 2019

Time: 8:00 am to 4:00 pm

Location: FDA White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
FDA Campus Information, (e.g., local airports, directions, and local hotels)

Background:

There is a paucity of effective treatments for patients with central nervous system (CNS) metastases. Moreover, there are few clinical trials and a need for more attention to this high unmet medical need. One impediment to product development for CNS metastases is uncertainty on the optimal clinical trial endpoints and study designs for evaluating products. This unique workshop will bring key stakeholders together to evaluate what is needed to advance development of effective products and consider optimal endpoints and clinical trial designs related to this topic.

Workshop Goals and Objectives:

• To provide a forum for open discussion among FDA, clinicians, researchers, patient advocates, and industry in neuro-oncology product development on clinical trials for patients with brain metastases
• To discuss and work toward identifying endpoints for clinical trials for patients with brain metastases
• To educate researchers and product developers about relevant regulatory science and policy issues important to CNS metastasis product development
• To accelerate the development of products for the treatment of CNS metastases
• Facilitate open discussions among major stakeholders in the field of CNS metastases

Webcast Information Replay:

Opening – Session II:  https://collaboration.fda.gov/p1s1r7ochw0u/

Session III - Lunch:  https://collaboration.fda.gov/p178xjsvyode/

Post-Lunch Session III:  https://collaboration.fda.gov/puj6tld22ylg/

Session IV - Adjourn:  https://collaboration.fda.gov/pddyrrv7zn5c/

Workshop Information:

• Background Information: Pre-Workshop Educational Videos
  • Non-Small Cell Lung Cancer and Brain Metastases - https://vimeo.com/321238545/d8e4285af1 Dr. Ross Camidge, Director of Thoracic Oncology at the University of Colorado Cancer Center, provides a primer on Non-small cell lung cancer and brain metastases.
  • CNS Metastases from Melanoma: The Role of Systemic Therapy - https://vimeo.com/321238550/cb003eb745 Dr. Michael Davies, Deputy Chairman of MD Anderson Cancer's Center for Melanoma Medical Oncology on the role of systemic therapy for CNS metastases from melanoma.
  • Radiotherapy in the Management of Brain Metastases - https://vimeo.com/321234317/33959e4ee9 Dr. Paul Brown, Professor of Radiation Oncology at the Mayo Clinic, discusses radiotherapy in the current management of brain metastases.
  • Systemic Therapy for Breast Cancer Brain Metastases - https://vimeo.com/321238559/2e386b8fda Dr. Nancy U. Lin, Associate Chief of Dana-Farber Cancer Institute's Breast Oncology Division, presents on the current treatments of breast cancer brain metastases and where the science currently stands to find a systemic therapy.
  • Leptomeningeal Metastasis - https://vimeo.com/321233589/90c96c6991 Dr. Emilie Le Rhun, Physician in Neurology & Neurosurgery, at the Centre Hospitalier Régional et Universitaire (CHRU) de Lille, presents the latest findings, standard of care, and the main challenges in treating Leptomeningeal Metastasis.
• Agenda (PDF - 109 KB)
• Speaker Biographies (PDF - 189 KB)
• Workshop Committee (PDF - 248 KB)
• Presentations
  • Opening Remarks and Presenting the Challenges (PDF - 2.22MB)
  • Clinical Management of CNS Metastases- Current Treatments and Investigations (PDF - 1.68MB)
  • Identification of Targets Brain Metstases Clinical Trials (PDF - 2.14MB)
  • Selecting Drug Candidates for Treatment of Brain Metastases (PPT - 3.78MB)
  • Issues in Conducting Clinical Trials for Patients with Brain Metastates (PDF - 500KB)
  • Standardizing Brains Mets Response Assessment (PDF - 1.33MB)
  • The Multiple Facets of Clinical Benefit (PDF - 465KB)
  • Regulatory Challenges with Trials Seeking CNS Efficacy Claims (PDF - 186KB)
  • Overview Am Brain Tumor Assoc Metastatic Brain Tumor Initiative (PDF - 318KB)
  • Summary and Next Steps- Discussion Only (PDF - 264KB)

NBTS Meeting Condensed Transcript with index (PDF - 5.44MB)

NBTS Meeting Full Transcript (PDF - 975KB)

Contact:

Joan Ferlo Todd, RN
Regulatory Health Project Manager
Office of Hematology and Oncology Products (OHOP)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration
[email protected]

Sarah O'Connor
Executive Assistant
National Brain Tumor Society
55 Chapel Street, Suite 200
Newton, MA 02458
[email protected]
Facebook: @braintumors; Twitter: #MetsCNS2019; #CNSMetsWorkshop2019; www.braintumor.org