As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Reg­u­la­tors didn’t keep As­traZeneca and Dai­ichi Sankyo wait­ing long at all for their lat­est En­her­tu ap­proval.

The part­ners pulled a win on Fri­day in HER2-low breast can­cer pa­tients who’ve al­ready failed on chemother­a­py, less than two weeks af­ter its sup­ple­men­tal BLA was ac­cept­ed. While this isn’t the FDA’s fastest ap­proval — Bris­tol My­ers Squibb won an OK for its block­buster check­point in­hibitor Op­di­vo in just five days back in March — it comes well ahead of En­her­tu’s orig­i­nal Q4 PDU­FA date.

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