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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