Iovance Biotherapeutics (IOVA) Provides Regulatory Update for Lifileucel Potency Assays, BLA Submission Now Expected H1 2022

(Updated - May 18, 2021 4:36 PM EDT)

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced receipt of regulatory feedback from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel. Previously, the company reported the submission of assay data to the FDA and recently the FDA provided comments regarding the data package.

Following FDA feedback, Iovance will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet with the FDA in the second half of 2021. The company's biologics license application (BLA) submission for lifileucel is now expected to occur during the first half of 2022.

“TIL is a first-in-class, one-time administration cell therapy and the first potential BLA for a cell therapy in solid tumors,” stated Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. “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.”

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