The US Food and Drug Administration (FDA) has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) as the first cellular therapy to treat patients with unresectable or metastatic melanoma.

The therapy has been specifically authorised under the FDA’s accelerated approval pathway for use in adults who have received prior treatment with a PD-1 inhibitor and a BRAF inhibitor if the tumour carries the BRAF V600 mutation.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the approval “represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options”.

Despite melanoma, a form of skin cancer that is often caused by exposure to ultraviolet light, only representing around 1% of all skin cancer, the FDA reports that the disease accounts for a “significant number of cancer-related deaths”.

Until now, there have been no FDA-approved treatment options for patients with advanced melanoma whose disease progressed following initial treatment with an immune checkpoint inhibitor and, if appropriate, targeted therapy.

Administered as a single dose for infusion, Amtagvi is a tumour-derived autologous T cell immunotherapy composed of a patient’s own T cells, a type of cell that helps the immune system fight cancer.

The regulator’s decision, which makes Amtagvi the first one-time, individualised T cell therapy to receive US approval for a solid tumour cancer, was supported by positive results from the C-144-01 clinical trial.

Results showed that 31.5% of 73 patients who had previously received an anti-PD-1 therapy achieved an objective response rate, with 43.5% of responses having a duration greater than one year.

Additionally, in a supporting pooled efficacy analysis that included 153 patients, 31.4% achieved an objective response and 54.2% of responses were maintained at one year.

Iovance is also conducting a phase 3 trial to confirm the clinical benefit of Amtagvi.