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

Iovance Biotherapeutics Provides Regulatory Update for Lifileucel Potency Assays

SAN CARLOS, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- 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... More