FDA rais­es big safe­ty is­sues in No­var­tis’ CAR-T re­view, but spot­lights post-mar­ket­ing path for­ward

The FDA’s in-house re­view of No­var­tis’ ground­break­ing CAR-T ther­a­py ti­s­agen­le­cleu­cel (CTL019) came out this morn­ing, care­ful­ly out­lin­ing the ef­fi­ca­cy tracked in Phase II and hon­ing in on the agency’s big con­cern: How do ex­perts in the field view the se­ri­ous safe­ty is­sues re­main and what would be the best way to track and con­tain them once mar­ket­ing be­gins?

“The over­all ef­fec­tive­ness of this prod­uct is not the pri­ma­ry is­sue for con­sid­er­a­tion by this Com­mit­tee,” states the re­view doc­u­ment. But the Phase II study in pa­tients with B-cell acute lym­phoblas­tic leukemia raised a host of is­sues on short-term and po­ten­tial­ly lethal dan­gers, from a high though fa­mil­iar rate of cy­tokine re­lease syn­drome to the neu­ro­log­i­cal con­di­tions that CRS can trig­ger.

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