Iovance Biotherapeutics Inc (NASDAQ:IOVA) has received regulatory feedback from the U.S. Food and Drug Administration (FDA) on its potency assays for lifileucel.
Following FDA feedback, Iovance will have to submit additional assay data and meet with the FDA in the second half of 2021.
Meanwhile, the company will continue its ongoing work developing and validating its potency assays.
The company’s marketing application submission for lifileucel is now expected to occur during the first half of 2022. Earlier the submission was expected during 2021.
“TIL is a first-in-class, one-time administration cell therapy and the first potential BLA for a cell therapy in solid tumors,” stated CEO Maria Fardis.
“As such, TIL product is complex by nature and alignment with FDA on a potency assay is an important step toward BLA submission. With a regenerative medicines advanced therapy (RMAT) designation for lifileucel, FDA recognizes the unmet need for patients with metastatic melanoma who progress after anti-PD1 therapy.”
Iovance aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers.
Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient.
IOVA shares were down $3.64, or 13.5% at $23.33 early Wednesday.