FDA hits Iovance with one more delay for TIL therapy, extending BLA filing until 2023
Iovance Biotherapeutics is once again pushing back its filing plans for its cell therapy — the latest in a three-year streak of delays — although execs say this one won’t take long to resolve.
While the company began a rolling BLA submission in August, the FDA recently raised new questions about “supplemental assay validation information and comparability data” for its drug. To address those comments, Iovance now expects to complete its filing in Q1 2023.
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