Dai­ichi Sankyo gets a “break­through” at the FDA; In­Vi­vo re­struc­tures, cuts jobs

⇨ There’s lots of news about an­ti­body-drug con­ju­gates to­day. Of note, the FDA has giv­en Dai­ichi Sankyo’s HER2-tar­get­ing ADC DS-8201 its break­through drug des­ig­na­tion, promis­ing to help speed it through to a mar­ket­ing de­ci­sion. Reg­u­la­tors based their de­ci­sion on da­ta from an on­go­ing Phase I study. “The Break­through Ther­a­py des­ig­na­tion for DS-8201 in HER2-pos­i­tive metasta­t­ic breast can­cer ac­knowl­edges the un­met med­ical need these pa­tients face when cur­rent­ly ap­proved treat­ments no longer con­trol their dis­ease,” said An­toine Yver, the on­col­o­gy R&D chief for Dai­ichi Sankyo.

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