Nek­tar’s pitch on ear­ly can­cer drug OK runs in­to a reg­u­la­to­ry brick wall

Nek­tar Ther­a­peu­tics’ $NK­TR at­tempt to win an ac­cel­er­at­ed Eu­ro­pean OK for its can­cer drug Onzeald (NK­TR-102) has run straight in­to a reg­u­la­to­ry brick wall.

The CHMP has vot­ed thumbs down on Onzeald, which is al­so bad news for Dai­ichi Sankyo, which bet $20 mil­lion up­front on a re­gion­al li­cens­ing pact for the drug.

Nek­tar and Dai­ichi Sankyo were gam­bling on an ear­ly OK for this drug af­ter re­searchers ex­tract­ed da­ta from their BEA­CON study on 67 ad­vanced breast can­cer pa­tients with a his­to­ry of brain metas­tases. That da­ta min­ing project de­liv­ered a 5.2-month over­all sur­vival ben­e­fit in the drug group com­pared with a con­trol group who were giv­en a physi­cian’s choice of ther­a­pies.

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