The U.S. Food and Drug Administration (FDA) awarded Amgen’s cancer antibody drug, bemarituzumab, Breakthrough Therapy Designation for a first-line treatment for specific kinds of gastric cancer. The decision comes after the FDA reviewed data from Phase II FIGHT study that demonstrated three efficacy endpoints: overall survival, progression-free survival, and overall response rate. With an estimated 1 million new cases of gastric cancer diagnosed annually, Amgen expects Asia, which predominantly sees a higher rate of diagnoses than other regions, to be an important market for bemarituzumab.
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