As­traZeneca nabs break­through sta­tus, as $7B ADC races to block­buster sta­tus

A rapid breast can­cer ap­proval came just be­fore New Year’s for As­traZeneca and Dai­ichi Sankyo’s bil­lion-dol­lar an­ti­body drug con­ju­gate En­her­tu, but the plan was nev­er to stop there.

To­day, As­traZeneca said they re­ceived break­through sta­tus for En­her­tu in HER2-pos­i­tive non-small cell lung can­cer. It’s the sec­ond such des­ig­na­tion they’ve re­ceived in a week, af­ter the FDA grant­ed the same recog­ni­tion to En­her­tu in gas­tric can­cer. The twin des­ig­na­tions set the British drug­mak­er up to mar­ket the drug in three dif­fer­ent in­di­ca­tions, a key val­i­da­tion for the mas­sive deal CEO Pas­cal So­ri­ot signed in 2019.

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