Learning Objectives

1. To define the role of PD-L1 in selecting patients for front line immunotherapy. Understand expedited review processes of the FDA, including accelerated approval, fast track designation, and Breakthrough therapy designation

2. Understand recent initiatives by the Oncology Center of Excellence, including Project Orbis, Project Facilitate, Project Real Time Review

3. Understand the evolution of oncology drug review and development in a four decade perspective