FDA Approves TIL Therapy for Unresectable or Metastatic Melanoma


Lifileucel is the first TIL therapy approved by the FDA for a solid tumor, specifically previously treated unresectable or metastatic melanoma.

FDA Approves TIL Therapy for Unresectable or Metastatic Melanoma

FDA Approves TIL Therapy for Unresectable or Metastatic Melanoma

The FDA has granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for the treatment of adults with unresectable or metastatic melanoma that was previously treated with a PD-1 blocking antibody and a BRAF inhibitor with or without a MEK inhibitor if the patient’s disease is BRAF V600 positive.1

This marks the first and only individualized T-cell therapy approved by the FDA for a solid tumor, according to a press release from Iovance, the manufacturer of the therapy.2

“The accelerated approval of Amtagvi is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance, said in the release.2 “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

The approval was based on findings from the C-144-01 clinical trial, which assessed lifileucel in patients with advanced melanoma previously treated with an anti-PD-1 therapy and targeted therapy, if applicable. Lifileucel was given to patients after a lymphodepleting regimen of 60 mg/kg of cyclophosphamide daily with mesna for 2 days, followed by 25 mg/m2 of fludarabine daily for 5 days.1 Between 3 to 24 hours after infusion, patients received 600,000 IU/kg of IL-2 (aldesleukin) every 8 to 12 hours for up to 6 doses to support cell expansion in vivo. The median doses of lifileucel administered was 21.1 x 109 viable cells, and the median number of IL-2 doses given was 6, according to the FDA.

Among the 73 patients from Cohort 4 in this trial, 31.5% (95% CI, 21.1%-43.4%) achieved an objective response by RECIST 1.1.1 At 18.6 months of follow-up, the median duration of response was not reached (95% CI, 4.1-not reached), and 43.5% of responses lasted longer than 12 months.2

Of the 153 patients from Cohort 4 and 2 from the trial, 31.5% achieved an objective response by RECIST 1.1, and the median duration had not been reached at 21.5 months of follow-up. In patients from this group that responded to treatment, 54.2% had responses that lasted longer than 12 months.

“The approval of Amtagvi offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” said Samantha R. Guild, J.D., President of AIM at Melanoma Foundation, in the Iovance release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

According to the FDA, the prescribing information for lifileucel contains a Boxed Warning for prolonged severe cytopenia, treatment-related mortality, cardiopulmonary and renal impairment, and severe infection. The most common adverse reactions, occurring in at least 20% of patients, included pyrexia, chills, tachycardia, fatigue, febrile neutropenia, diarrhea, alopecia, rash hypotension, edema, hypoxia, infection, and dyspnea.

The recommended dose of lifileucel is 7.5 x 109 to 72 x 109 viable cells.


  1. FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma. FDA. February 16, 2024. Accessed February 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma
  2. Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma. Yahoo Finance. February 16, 2024. Accessed February 16, 2024. https://finance.yahoo.com/news/iovance-amtagvi-lifileucel-receives-u-201900117.html
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