Amgen's promising gastric cancer drug makes good on Five Prime potential with FDA's breakthrough nod
When Five Prime — now part of Amgen — rolled out mid-stage data for gastric cancer candidate bemarituzumab late last year, it looked like a big win with one major catch: The drug missed its OS primary endpoint. Even still, there was enough promise for Amgen to jump aboard, and apparently, the FDA is interested, too.
On Tuesday, the FDA granted bemarituzumab, an anti-FGFR2b antibody, a Breakthrough Therapy Designation for gastric cancer. The drug would be the first of its kind to target FGFR2b, which is overexpressed in about 20% of HER2-negative tumors.
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