Scientific Advisory Committee on Oncology Therapies: Announcement of Meeting – June 14, 2019

Ottawa, Ontario
May 28, 2019

The purpose of this Notice is to announce an upcoming meeting of Health Canada's Scientific Advisory Committee on Oncology Therapies (SAC-OT).

The advice received from this meeting will be used to facilitate and enhance the pre- and post-market review of tumour agnostic cancer treatments.

Mandate of the SAC-OT

The SAC-OT will provide Health Canada with scientific, technical, medical and clinical advice on the evaluation of safety, efficacy, and effectiveness regarding this new therapeutic paradigm for treating cancer.

For more details on the mandate of the SAC-OT, please refer to the Terms of Reference of the SAC-OT.

Meeting Format

Health Canada will present the regulatory review context while Canadian experts will provide clinical and research perspectives in this area of advanced oncology therapeutics. The SAC-OT will, in turn, address questions regarding tumor agnostic therapies in relation to Health Canada’s review processes.

Upon completion of the presentation and following discussion, the Committee will deliberate before providing recommendations to Health Canada.

Agenda

The following topics regarding tumour agnostic cancer treatments will be discussed:

• current pre-market regulatory requirements and its challenges
• post-market considerations to develop suitable risk management plans and
• the implications to traditional oncology practices and the healthcare system

A more detailed agenda will be posted in the coming weeks.