FDA pad­locks any new hu­man tests on Seat­tle Ge­net­ics’ can­cer drug in the wake of more deaths

In the wake of Seat­tle Ge­net­ics’ an­nounce­ment that a dis­turb­ing tilt in deaths point­ed to a like­ly safe­ty prob­lem for its late-stage can­cer drug vadas­tux­imab talirine (SGN-CD33A), the FDA has stepped in to yank the IND and of­fi­cial­ly put any hu­man test­ing on hold.

The biotech $SGEN re­port­ed the FDA’s move in a fil­ing with the SEC this morn­ing.

Seat­tle Ge­net­ics had al­ready hit the brakes on its R&D work on the drug three days ago, scrap­ping the Phase III for acute myeloid leukemia and or­der­ing a halt to any oth­er test­ing un­til they can get a bet­ter read on the sit­u­a­tion. It will al­so have to con­vince reg­u­la­tors that the drug is safe for test­ing— af­ter the FDA had lift­ed its first clin­i­cal hold on the drug just three months ago. That first hold on its ear­ly-stage work came af­ter four pa­tients died.

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