ASCO GI 2021 | FDA considerations for approval of therapies in GI cancers

Lola A. Fashoyin-Aje, MD, MPH, U.S. Food and Drug Administration, discusses recently approved therapies in hepatobiliary and esophagogastric cancers, including approval pathways, how clinical trial designs can help support approvals as well as the importance of biomarkers in clinical development. Dr Fashoyin-Aje also discusses the latest FDA approved therapies, including the combination atezolizumab and bevacizumab for unresectable hepatocellular carcinoma (HCC) in the first-line setting, a practice-changing approval based on the results of the IMbrave150 study (NCT03434379), as well as nivolumab and ipilimumab for refractory HCC. Finally, Dr Fashoyin-Aje outlines the approval of pemigatinib, an FGFR2 inhibitor, for use in FGFR2b-mutant cholangiocarcinoma. This interview was recorded via an online conference call with The Video Journal of Oncology (VJOncology).