Amgen Awarded Breakthrough Designation for Acquired Cancer Antibody Drug

One month after snapping up Five Prime Therapeutics and its Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion, Amgen announced the U.S. Food and Drug Administration (FDA) awarded Breakthrough Therapy Designation to the asset as a first-line treatment for certain types of gastric cancer.

Late Monday, Amgen announced the investigational drug bemarituzumab received the FDA’s designation for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma. The designation was based on data from the Phase II FIGHT study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Data from the study, announced in November 2020, shows all three efficacy endpoints of progression-free survival, overall survival and overall response rate were met.

Amgen R&D Head David M. Reese said the FIGHT trial is the first study that evaluated targeting the overexpression of FGFR2b in cancer. He said bemarituzumab as a front-line therapy demonstrated “clinically meaningful outcomes” in those three key endpoints in patients diagnosed with advanced gastric or gastroesophageal cancer. He added the company looks forward to moving bemarituzumab into Phase III and is already discussing potential paths to approval with various regulatory bodies.

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