The US Food and Drug Administration (FDA) has approved Amtagvi (lifileucel), the first one-time cell therapy for patients with advanced melanoma.
After 40 years in the making, Iovance Therapeutics' Amtagvi was approved by the FDA through the Accelerated Approval pathway last Friday. The cell therapy is a tumor-derived autologous T-cell immunotherapy, which consists of a patient’s own T-cells.
Amtagvi aims to treat adults with unresectable or metastatic melanoma (skin cancer), which has previously been treated with a PD-1 blocking antibody, and if the patient is BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Iovance said Amtagvi offers a “new” cell therapy approach. Tumor-infiltrating lymphocytes, (TILs) can identify cancer and then the immune system works to create TIL cells to find, fight, and destroy cancer. Furthermore, TIL therapies can target various cancer antigens in each individual patient.
“Melanoma is a life-threatening cancer that can cause devastating impacts to affected individuals, with a significant risk of metastasizing and spreading to other areas in the body,” said Nicole Verdun, director of the Office of Therapeutic Products in Center for Biologics Evaluation and Research (CBER).
“Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”
The therapy will be produced in Philadelphia, US at the firm’s Iovance Cell Therapy Center (ICTC), which opened in September 2021. The company said the facility has capacity for up to “several thousand patients annually,” as well as an undisclosed contract manufacturer located nearby.
Moreover, Iovance said it is expanding the center to “significantly” up the capacity over the next few years.
“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, interim CEO and President of Iovance, in a statement.
“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.”
Amtagvi is approved for autologous use only and comes with a black box warning (bbw) about risks of infection, mortality, cardiopulmonary and renal impairment, and low blood count.
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