There are currently no FDA approved therapies in this treatment setting.
Iovance Biotherapeutics, Inc., a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced it has completed its rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for lifileucel. 1
The San Carlos, California-based company is developing novel T cell-based cancer immunotherapies. Lifileucel is a tumor-infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma (unresectable or metastatic) who do not respond to immune checkpoint inhibitors. Startup activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for lifileucel in advanced post-anti-PD-1 melanoma.
The BLA is supported by data from 153 patients with advanced melanoma enrolled in cohort 2 (n = 66) and cohort 4 (n = 87) of the phase 2 C-144-01 trial in patients with advanced post-anti-PD1 melanoma. (NCT02360579).2 Following receipt of the complete rolling BLA submission for lifileucel, the FDA has 60 days to determine the acceptability of the BLA for review. Iovance is pursuing accelerated approval in this indication and said it reached an agreement with the FDA regarding the registrational trial design for the Phase 3 trial of lifileucel, in combination with pembrolizumab in frontline advanced melanoma. The FDA also previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.
In a press release, Frederick Vogt, Ph.D., J.D., Interim President, and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.”
1. Iovance Biotherapeutics completes biologics license application (BLA) submission for lifileucel in advanced melanoma. News release. Iovance Biotherapeutics. March 24, 2023. Accessed March 27, 2023. https://ir.iovance.com/news-releases/3/2023
2. Iovance Biotherapeutics announces updated clinical data for lifileucel in advanced melanoma at Society for Immunotherapy of Cancer (SITC) Annual Meeting. News release. Iovance Biotherapeutics. November 10, 2022. Accessed March 27, 2023. https://ir.iovance.com/news-releases/11/2022