Research & Development
Iovance Biotherapeutics' Amtagvi receives US FDA approval
19 February 2024 -

Iovance Biotherapeutics Inc, a United States-based biopharmaceutical startup, announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for its Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that has previously been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).

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. A portion of the patient's tumour tissue is removed during a surgical procedure prior to treatment. The patients' T cells are separated from the tumour tissue, further manufactured and then returned to the same patient as a single dose for infusion. This is the first FDA-approved tumour-derived T cell immunotherapy.

Amtagvi was approved through the Accelerated Approval pathway, under which the FDA may approve drugs for serious or life-threatening illnesses or conditions where there is an unmet medical need and the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients (improving how patients feel or function, or whether they survive longer).

The safety and effectiveness of the product was assessed in a global, multicentre, multicohort clinical study that includes adult patients with unresectable or metastatic melanoma who had earlier been treated with at least one systemic therapy, including a PD-1 blocking antibody, and if positive for the BRAF V600 mutation, a BRAF inhibitor or BRAF inhibitor with an MEK inhibitor.