FDA Pushes Back Decision on Lifileucel for Advanced Melanoma Treatment


A new target action date has been set as the FDA continues to consider approving lifileucel for the treatment of advanced melanoma.

  • A new Prescription Drug User Fee Act target action date of February 24, 2024, has been set for the biologics license application (BLA) for lifileucel as treatment of advanced melanoma.1

  • The FDA is working with the developer of lifileucel to expedite the lengthier review process.

  • If granted FDA approval, lifileucel will be the first individualized, 1-time cell therapy for patients with advanced melanoma.

The FDA is extending its review of the BLA for lifileucel (LN-144), a potential treatment for patients with advanced melanoma.1

The BLA was previously granted priority review by the FDA and was being considered for accelerated FDA approval. However, the FDA informed Iovance Biotherapeutics, Inc., that the agency’s resources were insufficient to complete a quickly review a recent response to an information request. The FDA has therefore set a new Prescription Drug User Fee Act target action date of February 24, 2024.

The proposed indication for lifileucel is backed by data from the C-144-01 clinical trial (NCT02360579) of lifileucel in patients with advanced melanoma who progressed on or after prior anti-PD-1/PD-L1 therapy and targeted therapy.

Efficacy data from 153 patients in cohort 2 (n = 66) and cohort 4 (n = 87) of the study show that at median follow-up was 36.5 months, and the overall response rate was 31.4% (95% CI, 24.1%-39.4%). Responses included 9 complete responses (CRs) and 39 partial responses (PRs). The median duration of response was not reached at 36.5 months. Notably, 42% of responses lasted for 24 months or more.

The median time from lifileucel infusion to best response in the study was 1.5 months, and responses deepened over time. Initial PRs converted to CRs in 7 patients as late as 2 or more years after receiving lifileucel. This included 1 conversion to CR in approximately 10 months since the initial data analysis.2,3

The treatment-emergent adverse events (TEAEs) observed were consistent with the known AE profiles of nonmyeloablative lymphodepletion and interleukin-2. The incidence of TEAEs rapidly decreased within the first 2 weeks following lifileucel infusion.

Despite delaying the decision on the BLA for lifileucel, the FDA has agreed to work closely with Iovance Biotherapeutics, in an effort to speed up the review process.


1. U.S. Food and Drug Administration updates Prescription Drug User Fee Act (PDUFA) action date for lifileucel for the treatment of advanced melanoma. New release. Iovance Biotherapeutics, Inc. September 14, 2023. Accessed September 15, 2023. https://tinyurl.com/rubps73b

2. Iovance Biotherapeutics announces U.S. food and drug administration acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma. News release. Iovance Biotherapeutics, Inc. May 26, 2023. Accessed September 15, 2023. https://tinyurl.com/2ku25fnv

3. Iovance Biotherapeutics announces updated clinical data for lifileucel in advanced melanoma at society for immunotherapy of cancer (SITC) annual meeting. News release. Iovance Biotherapeutics, Inc. November 10, 2022. Accessed September 15, 2023. https://tinyurl.com/4yfc2h4d

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