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# Iovance Biotherapeutics BLA for Melanoma Therapy
- URL: https://www.fdaweb.com/iovance-biotherapeutics-bla-for-melanoma-therapy/
- Published: 2022-08-25T12:00:00.000Z
- Updated: 2026-09-14T17:57:24.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152588

Iovance Biotherapeutics has begun a rolling BLA for lifileucel, a tumor infiltrating lymphocyte therapy for use in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. The company says it plans to complete the BLA submission in the fourth quarter.

The BLA is based on clinical [data](https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-positive-clinical-data?ref=fdaweb.com) from the company’s C-144-01 clinical trial. As reported in May, Cohort 4 from the study showed an objective response rate (ORR) of 29%, with three complete responses and 22 partial responses, the company says. The median duration of response was 10.4 months with a median study follow-up of 23.5 months. “These data demonstrate that one-time treatment with lifileucel therapy may provide meaningful benefit in heavily pre-treated patients,” it says. Cohort 4’s findings are supported by Cohort 2, where the ORR was 35% ,with five complete responses and 18 partial responses, the company adds.

The company says that the therapy uses a patient’s own immune cells to attack solid tumors. In 2021, Iovance delayed the BLA submission after receiving FDA regulatory feedback on potency assays for the product. Previously, FDA granted a regenerative medicines advanced therapy designation for lifileucel.