One-Time Cell Therapy Lifileucel Under Review for Advanced Melanoma

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A regulatory decision is expected on November 25, 2023.

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for lifileucel for the treatment of patients with advanced melanoma.

Lifileucel is a novel polyclonal tumor infiltrating lymphocyte therapy. The application is supported by data from the C-144-01 study ( Identifier: NCT02360579), which evaluated lifileucel in adults with unresectable or metastatic melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The efficacy analysis included 153 patients; all patients had progressed on or after immune check point inhibitor therapy and targeted BRAF/MEK inhibitor therapy where appropriate.

After a median study follow-up of 36.5 months, the objective response rate was 31.4% (95% CI, 24.1-39.4), with 9 complete responses and 39 partial responses. Median time to best response was 1.5 months. Median duration of response was not reached, with 41.7% of responders having responses lasting for 24 months or longer.

Findings also showed that median overall survival (OS) had not been reached (95% CI, 30.4-not reached) among patients who achieved a response at first assessment (6 weeks). Among all patients, median OS was 13.9 months (95% CI, 10.6-17.8).

“The BLA acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, one-time cell therapy for a solid tumor,” said Frederick Vogt, PhD, JD, Interim President and CEO of Iovance. “The FDA’s commitment to a 6-month Priority Review validates the unmet need and urgency for new treatment options for patients with advanced melanoma who have progressed on or after standard of care therapies.”

A Prescription Drug User Fee Act target date of November 25, 2023 has been set for the application.

The Company is also investigating lifileucel in patients with untreated, unresectable or metastatic melanoma in the phase 3 TILVANCE-301 trial ( Identifier: NCT05727904). This will serve as the confirmatory study to support full approval if lifileucel receives accelerated approval.


  1. Iovance Biotherapeutics announces US Food and Drug Administration acceptance of the Biologics License Application of lifileucel for the treatment of advanced melanoma. News release. Iovance Biotherapeutics. Accessed May 31, 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 May 31, 2023.