Not ‘TIL’ 2024: Iovance’s lifileucel faces yet another approval delay, this time due to FDA resource constraints

Io­vance Bio­ther­a­peu­tics’ bid for ap­proval of its melanoma ther­a­py has been hit with its fourth year of de­lay, as FDA re­source con­straints forced the agency to add three months to its tar­get ac­tion date.

The FDA ac­cept­ed the BLA for Io­vance’s tu­mor in­fil­trat­ing lym­pho­cyte ther­a­py (TIL), li­fileu­cel, for ad­vanced melanoma un­der pri­or­i­ty re­view in May, when it set a PDU­FA date of Nov. 25.

But the reg­u­la­tor has now told Io­vance it lacks the re­sources need­ed to re­view the com­pa­ny’s re­cent re­sponse to an in­for­ma­tion re­quest, ne­ces­si­tat­ing an ex­ten­sion to Feb. 24, 2024. Io­vance’s stock price $IO­VA dropped by 16% to $4.52 on Sep. 14, but it’s jumped 12% in pre­mar­ket trad­ing.

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