FDA-NBTS Public Workshop: Product Development for CNS Metastases

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:

FDA will provide a free-of-charge, live webcast of this workshop. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date.

FDA plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.