FDA hits Io­vance with one more de­lay for TIL ther­a­py, ex­tend­ing BLA fil­ing un­til 2023

Io­vance Bio­ther­a­peu­tics is once again push­ing back its fil­ing plans for its cell ther­a­py — the lat­est in a three-year streak of de­lays — al­though ex­ecs say this one won’t take long to re­solve.

While the com­pa­ny be­gan a rolling BLA sub­mis­sion in Au­gust, the FDA re­cent­ly raised new ques­tions about “sup­ple­men­tal as­say val­i­da­tion in­for­ma­tion and com­pa­ra­bil­i­ty da­ta” for its drug. To ad­dress those com­ments, Io­vance now ex­pects to com­plete its fil­ing in Q1 2023.

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