FDA-BCAN Workshop

June 26, 2019

Co-sponsored by the: U.S. Food and Drug Administration (FDA) and the Bladder Cancer Advocacy Network (BCAN)

Date:          Thursday, August 8, 2019 from Noon-4PM EST

Location:   Capital Hilton, 1001 16^th Street NW, Washington, DC 20036

Cost:          Free – WebEx Only

Neoadjuvant cisplatin-based combination chemotherapy followed by radical cystectomy is a standard treatment for muscle-invasive urothelial cancer of the bladder. This workshop brings together stakeholders in the care of patients with muscle-invasive bladder cancer including clinicians, regulatory scientists, biostatisticians, patients, advocates, and industry representatives to:

• define the current state of knowledge regarding endpoints to accelerate the development of systemic therapy regimens in the neoadjuvant setting.
• identify knowledge gaps.
• plan strategies for evidence development.
• generate regulatory guidance to inform ongoing/future clinical trials.

Who Should Attend

This workshop is for academic experts from all relevant disciplines including medical oncology and urology, interested representatives of pharmaceutical companies, regulatory agencies, patient advocates, scientists, clinicians, biostatisticians and interested members of regulatory government agencies in the US and abroad.

Join us via WebEx, register now: https://bit.ly/2NJpWlO

Goals and Objectives – For workshop agenda, click here. 

• To provide a forum for open discussion between clinicians, regulatory scientists, biostatisticians, patients, advocates, and industry regarding the role of pathologic complete response rate as an endpoint to accelerate the development of novel neoadjuvant systemic therapies for the treatment of muscle-invasive bladder cancer.
• To seek feedback from multiple stakeholders on the role of other endpoints (e.g., event-free survival), and standardize definitions for such endpoints for the development of novel neoadjuvant systemic therapies for the treatment of muscle-invasive bladder cancer.
• To obtain input from multiple stakeholders on approaches to document clinical complete response with neoadjuvant systemic therapy for the treatment of muscle-invasive bladder cancer, to elucidate the clinical relevance of clinical complete response, and to define trials designs and endpoints (e.g., cystectomy-free survival) to advance a potential therapeutic strategy of using systemic therapy alone as a curative-intent approach to the treatment of muscle-invasive bladder cancer.
• To map out priorities for further evidence development to address knowledge gaps.