FDA grants Enhertu tumor-agnostic accelerated approval

The FDA on Fri­day gave Dai­ichi Sankyo and As­traZeneca’s an­ti­body-drug con­ju­gate En­her­tu a tu­mor-ag­nos­tic in­di­ca­tion un­der ac­cel­er­at­ed ap­proval. It’s the first such ap­proval for a HER2-di­rect­ed ther­a­py — and the first an­ti­body-drug con­ju­gate to get a tu­mor-ag­nos­tic in­di­ca­tion from the FDA.

The FDA ap­proved En­her­tu for adults with ad­vanced HER2-pos­i­tive sol­id tu­mors who have re­ceived pri­or sys­temic treat­ment and have no good op­tions left. The block­buster an­ti­body-drug con­ju­gate was pre­vi­ous­ly ap­proved for cer­tain breast can­cer, lung can­cer and stom­ach can­cer pa­tients.

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