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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