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Iovance Biotherapeutics Provides Update for Lifileucel in Metastatic Melanoma
SAN CARLOS, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today provided a regulatory update for its tumor-infiltrating lymphocyte (TIL) therapy lifileucel in metastatic melanoma. In preparation for the planned Biologics License Application (BLA) submission for lifileucel, the Company has been engaged in discussions with the U.S. Food and Drug Administration (FDA), including a recent Type B meeting, regarding the requirements and timing of certain information that would be provided as part of its BLA submission. \n The Company believes that clinical data from its C-144-01 trial supports the potential for lifileucel as a treatment for metastatic melanoma. Iovance and the FDA have reached agreement on the duration of follow up for its pivotal Cohort 4 to support the BLA submission. As part of the Type B meeting, the Company and the FDA have not been able to agree on the required potency assays to fully define its TIL therapy, which is required as part of a BLA submission. The Company is continuing to refine the information from its current potency assays and simultaneously developing additional assays. As a result of these developments, the BLA submission is not expected by the end of 2020. The Company will continue to work closely with the FDA and now anticipates a BLA submission to occur in 2021. Additional guidance on the BLA submission timing will be provided when available. “TIL is a first-in-class, one-time administration cell therapy targeting solid tumors. As such, definition of the product through a potency assay is an important step toward submission of the BLA,” stated Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. “We have agreement with the FDA regarding the amount of clinical follow up for the BLA, and we will work closely with the FDA to reach alignment on our assays. Because Iovance recognizes the significant unmet need in the melanoma patient population and believes the compelling clinical data for lifileucel will offer a new therapy for such patients, we are moving ahead with a great sense of urgency. We look forward to further collaboration with the FDA and will provide updates as they become available.” As previously announced, updated Cohort 2 data from th...