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Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma


Lifileucel is a tumor-derived autologous T cell immunotherapy.



Iovance Biotherapeutics recently announced that the FDA approved lifileucel (Amtagvi) suspension for intravenous infusion for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Lifileucel’s indication is FDA- approved under an accelerated approval based on overall response rate and duration of response. Iovance is also conducting TILVANCE-301, a phase 3 trial to confirm the clinical benefit of lifileucel.

According to Iovance, lifileucel is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Lifileucel uses patient-specific T cells, also known as TIL cells, which are created by the immune system when cancer is detected to locate, attack, and destroy cancer cells. TIL cells can recognize distinctive tumor markers on the cell surface of each patient’s cancer.

The FDA accelerated approval of lifileucel is based on safety and efficacy data from the C-144-01 clinical trial. C-144-01 is a global, multicenter clinical trial investigating lifileucel in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy. The primary efficacy analysis set included 73 patients from cohort 4 who received the recommended lifileucel dose. Among the 73 patients, 31.5% achieved an objective response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) with a median duration of response not reached at 18.6 months follow-up. Additionally, 43.5% of responses had a duration greater than 12 months.

The supporting pooled efficacy set from C-144-01 included 153 patients from cohort 4 and cohort 2. Among the 153 patients, 31.4% achieved an objective response by RECIST 1.1 with a median duration of response not reached at 21.5 months follow-up. Of the 153 patients, 54.2% of responses had a duration greater than 12 months.

“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,” said Frederick Vogt, PhD, JD, the interim CEO and president of Iovance, in the news release. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”

According to the announcement, lifileucel is for autologous use only, and lifileucel has a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment. Clinicians should be aware of the boxed warning to properly inform patients of potential risks, but also to provide clarity and reassurance.

“One-time treatment with Amtagvi offered clinically meaningful and deep, durable responses in the Phase 2 clinical trial, and I am excited by its potential as a much-needed new treatment option for the many advanced melanoma patients who progress on the current standard of care,” said Alexander N. Shoushtari, MD, melanoma oncologist and cellular therapist at Memorial Sloan Kettering Cancer Center, in the news release. “This welcome news represents an important step forward in harnessing cell therapy to treat solid tumors,” added Dr. Jae Park, Chief of Cellular Therapy Service at Memorial Sloan Kettering Cancer Center.

To ensure access for all patients, IovanceCares is a support program available to patients. Physicians can call 833-400-4682 or visit www.iovancecares.com for more information for their patients.


Iovance’s AMTAGVI (lifileucel) receives US FDA accelerated approval for advanced melanoma. News release. Iovance Biotherapeutics. February 16, 2024. Accessed February 19, 2024. https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvitm-lifileucel-receives-us-fda-accelerated

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