Iovance Biotherapeutics‘ Amtagvi, a cellular therapy, has received accelerated approval from the US Food and Drug Administration (FDA) for adult patients with previously treated metastatic or unresectable melanoma.

This marks the first FDA-approved tumour-derived autologous T-cell immunotherapy, offering a new treatment option for individuals with this form of skin cancer.

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Amtagvi utilises the T cells of the patient extracted from tumour tissue and manufactured for re-infusion as a single dose.

It was approved by the regulator under the accelerated approval pathway, aimed at providing earlier access to promising treatments for serious ailments with unmet medical needs based on surrogate endpoints likely to predict clinical benefits.

A global, multicentre clinical study of adults with metastatic or unresectable melanoma who had previously undergone systemic therapy supported Amtagvi’s approval.

The effectiveness of Amtagvi was established by both the objective response rate and the duration of response, with a notable 31.5% of patients showing a response at the recommended dose.

Over half maintained their response without tumour progression or death at six months, with slightly lower percentages at nine and 12 months.

The treatment is not without risks, as patients may experience adverse reactions, including fever, chills, tachycardia, fatigue, diarrhoea, febrile neutropenia and oedema among others.

Atrial is underway to verify the clinical benefit of Amtagvi, as required by the FDA’s accelerated approval programme.

Amtagvi has previously obtained orphan drug therapy and regenerative medicine advanced therapy, fast track and priority review status from the regulator.

The FDA Center for Biologics Evaluation and Research director Peter Marks stated: “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal.

“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.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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