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# Iovance Biotherapeutics BLA for Melanoma Therapy
- URL: https://www.fdaweb.com/iovance-biotherapeutics-bla-for-melanoma-therapy-2/
- Published: 2023-03-27T12:00:00.000Z
- Updated: 2026-09-14T18:22:04.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154074

Iovance Biotherapeutics has completed a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte (TIL) therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The company says it is seeking an accelerated approval for the therapy.

The submission is based on clinical [data](https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-updated-clinical-data-0?ref=fdaweb.com) from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. “Iovance also reached [agreement](https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-provides-corporate-clinical-and?ref=fdaweb.com) with the FDA regarding the registrational trial design for the Phase 3 [TILVANCE-301](https://clinicaltrials.gov/ct2/show/NCT05727904?term=IOV-MEL-301&draw=2&rank=1&ref=fdaweb.com) trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma,” the company says. “TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting.”