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# Iovance Pushes Back BLA for Melanoma Therapy
- URL: https://www.fdaweb.com/iovance-pushes-back-bla-for-melanoma-therapy/
- Published: 2022-11-18T12:00:00.000Z
- Updated: 2026-09-14T18:07:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153233

Iovance Biotherapeutics has delayed until the first quarter next year its completion of a rolling BLA submission for lifileucel, an investigational tumor infiltrating lymphocyte therapy for patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and targeted BRAF/MEK inhibitor therapy.

“As part of an amendment to the ongoing investigational new drug application submitted during the third quarter of 2022, Iovance received recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel,” the company says. Iovance says it is addressing the agency comments in its submission, which will be completed before April.

The BLA is based on clinical [data](https://www.iovance.com/uploads/Sarnaik%5FSITC2022%5F24-oral-presentation%5FFINAL-compressed-2426-publication.pdf?ref=fdaweb.com) from the C-144-01 clinical trial in patients with advanced melanoma. The Phase 3 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma, which is expected to begin shortly, is intended to serve as a confirmatory study, the company says.