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FDA Grants Accelerated Approval to Iovance’s Amtagvi for Unresectable or Metastatic Melanoma


Amtagvi (lifileucel) becomes the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer.

Image credit: Christoph Burgstedt | stock.adobe.com

Image credit: Christoph Burgstedt | stock.adobe.com

The FDA has granted accelerated approval to Iovance’s Amtagvi (lifileucel) for adults with unresectable or metastatic melanoma who received prior treatment with a PD-1 antibody, and in patients who are BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor. The regulatory action makes Amtagvi the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer.1-3

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”1

The approval was based on findings from the global, multicenter, multicohort, open-label, single-arm Phase II C-144-01 trial (NCT02360579). Investigators enrolled patients who were at least 18 years of age with stage IIIC or stage IV unresectable or metastatic melanoma as determined by the American Joint Committee on Cancer v.7. Enrollment criteria included experiencing radiologic disease progression and progression after administration of at least one prior systemic therapy, including a PD-L1 antibody; and for patients with BRAF V600E mutation–positive disease, prior administration of a BRAF or BRAF/MEK inhibitor. The trial’s primary efficacy outcome measures included objective response rate (ORR) and duration of response (DOR).

The trial found that among those administered the recommended dose of Amtagvi (n = 73), ORR was 31.5%, with a complete response rate of 4.1% and a partial response rate of 27.4%.

Among responders to therapy, 56.5%, 47.8%, and 43.5% continued to respond without tumor progression or death at six, nine, and 12 months, respectively. Median DOR had not yet been reached, with a median time to initial response of 1.5 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,” Frederick Vogt, PhD, JD, interim CEO and president of Iovance, said in a press 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.”3

In terms of safety, the FDA noted that the prescribing information for Amtagvi includes a Boxed Warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment.

The most common adverse events observed in at least 20% of patients included chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“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,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, said in a 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.”3


1. FDA approves first cellular therapy to treat patients with unresectable or metastatic melanoma. News release. FDA. February 16, 2024. Accessed February 19, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma

2. FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma. FDA. February 16, 2024. Accessed February 19, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma

3. Iovance's Amtagvi (lifileucel) receives US FDA accelerated approval for advanced melanoma. News release. Iovance Biotherapeutics, Inc. 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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