Io­vance shares ham­mered on TIL ther­a­py fil­ing de­lay — al­though an­a­lysts aren't as both­ered

Io­vance won’t be able to file for its first-ever ap­proval by the end of this year af­ter all.

At is­sue is the po­ten­cy as­says Io­vance is us­ing to de­fine what would be the first-ever tu­mor-in­fil­trat­ing lym­pho­cyte (TIL) ther­a­py. Reg­u­la­tors want to have more da­ta on the cur­rent as­says, or po­ten­tial­ly see dif­fer­ent as­says in the BLA, the biotech sug­gest­ed.

All of that work would push the BLA sub­mis­sion in metasta­t­ic melanoma to 2021, when Io­vance has com­plet­ed the re­quired clin­i­cal fol­low-up and fin­ished re­fin­ing its as­says as well as de­vel­op­ing al­ter­na­tive ones. That means a launch won’t hap­pen un­til 2022 at the ear­li­est, with cer­vi­cal can­cer to fol­low in the same year.

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