CMC holdup de­lays Io­vance fil­ing again — to 2022 — as FDA seeks more as­say da­ta for TIL ther­a­py

Re­mem­ber those po­ten­cy as­says that tripped up Io­vance’s prepa­ra­tions for a BLA fil­ing? It turns out they may take even longer than ex­pect­ed to re­solve.

In a brief state­ment, the com­pa­ny di­vulged that the FDA wants to see more da­ta on the as­says — used to en­sure each batch of its tu­mor-in­fil­trat­ing lym­pho­cyte ther­a­py is up to stan­dard — in ad­di­tion to what it’s al­ready sub­mit­ted. Io­vance is now plan­ning to file for ap­proval in the first half of 2022, which amounts to a de­lay of more than a year from the orig­i­nal time­line of sub­mit­ting in 2020.

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