Up­dat­ed: FDA ex­plains why it won't pull Jaz­z's ac­cel­er­at­ed ap­proval de­spite a failed con­fir­ma­to­ry tri­al

When does a failed con­fir­ma­to­ry tri­al eval­u­at­ing over­all sur­vival not amount to a re­quest from FDA to pull an ac­cel­er­at­ed ap­proval for a can­cer drug? That’s the sit­u­a­tion right now for Jazz Phar­ma­ceu­ti­cals’ sec­ond-line treat­ment for adults with metasta­t­ic small cell lung can­cer, which it could spend up to $1 bil­lion to ac­quire, with $200 mil­lion up­front in 2019.

While the in­jec­tion, known as Zepzel­ca (lur­binecte­din), hit the mark for over­all re­sponse rate, pro­vid­ing enough to win its ac­cel­er­at­ed nod in June 2020, it then whiffed on an over­all sur­vival end­point six months lat­er as part of a Phase III study that was in­tend­ed to be the con­fir­ma­to­ry tri­al.

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