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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER