On April 20, 2021 Amgen reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to bemarituzumab for first-line treatment of 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) cancer (Press release, EVERSANA, APR 20, 2021, View Source [SID1234578243]).

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The designation was supported by the Phase II FIGHT trial, in which bemarituzumab treatment plus chemotherapy demonstrated clinically significant and substantial improvements in progression-free survival and overall survival in the patient population with at least 10% of tumor cells overexpressing FGFR2b.

"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients."

The designation makes bemarituzumab the second asset in Amgen’s oncology portfolio to receive Breakthrough Therapy Designation in the past six months – following sotorasib.