Lola A. Fashoyin-Aje, MD, MPH, U.S. Food and Drug Administration, outlines challenges associated with the approval of therapies for gastrointestinal (GI) malignancies and why approaches such as immunotherapy, which has been successful in other disease areas, has not been applicable to the GI space. This interview was recorded via an online conference call with The Video Journal of Oncology (VJOncology).