Amgen Gets Breakthrough Therapy Designation for Advanced Gastric Cancer Treatment

By Kimberly Chin

Amgen Inc. has received a breakthrough therapy designation by the U.S. Food and Drug Administration for a treatment that helps patients with advanced gastric or gastroesophageal cancer.

The drug, bemarituzumab, has shown clinically meaningful outcomes in patients with this kind of cancer, the company said. The designation, which helps expedite the development and regulatory review of medicines, paves the way for the drug to be used as a first-line treatment in combination with modified fluoropyrimidine, leucovorin and oxaliplatin, or FOLFOX6, the company said.

Bemarituzumab is the second therapy in Amgen's oncology portfolio to receive such designation in the past six months, Amgen said.

Write to Kimberly Chin at kimberly.chin@wsj.com

(END) Dow Jones Newswires

April 19, 2021 16:37 ET (20:37 GMT)

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