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FDA Approves First Cellular Therapy, Amtagvi, for Treatment of Metastatic Melanoma


17 February 2024

The FDA has approved Amtagvi, the first-ever cellular therapy for advanced melanoma, offering new hope for patients who have exhausted other treatments. This innovative approach uses modified T cells to fight melanoma, marking a significant advancement in cancer treatment.

The U.S. Food and Drug Administration (FDA) has heralded a new era in medical history with the approval of Amtagvi (lifileucel), a pioneering cellular therapy developed by Iovance Biotherapeutics, designed to combat advanced melanoma. Clinical trials show Amtagvi's 31.5% response rate in patients with previously progressing cancer. This innovative cell therapy employs a patient's own T cells, modified in the lab to better recognize and attack cancer cells, and then reintroduced into the patient's body to fight the tumor.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of this development, noting that unresectable or metastatic melanoma is an aggressive cancer form with potentially fatal outcomes. “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.”

The clinical trial that led to Amtagvi's approval demonstrated a high objective response rate among treated patients, a significant achievement considering these patients had previously seen their cancer progress after other treatments, including PD-1 inhibitors and BRAF inhibitors for those with specific genetic mutations. 

“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, CEO and President of Iovance. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.”

This one-time cell therapy has shown promise in transforming melanoma care, offering patients a new lease on life. As the first FDA-approved tumor-derived T cell immunotherapy, Amtagvi sets a new standard in cancer treatment, potentially paving the way for future therapies targeting other cancer types.

Among the 73 patients treated with Amtagvi at the recommended dose, the objective response rate was 31.5%, including three (4.1%) patients with a complete response and 20 (27.4%) patients with a partial response. Among those who responded to the treatment, 56.5%, 47.8%, and 43.5% continued to maintain responses without tumor progression or death at six, nine, and twelve months, respectively.

“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, M.D., director of the Office of Therapeutic Products in CBER. “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”

However, Amtagvi's journey to approval was not without its challenges. The therapy comes with a boxed warning about potential severe side effects, including low blood counts, infections, and cardiac disorders, underscoring the importance of close patient monitoring before and after treatment. Despite these risks, the medical community and patient advocacy groups have warmly received the FDA's decision, recognizing the critical need for innovative treatments in the battle against melanoma.

About AMTAGVI (lifileucel)

AMTAGVI (lifileucel) is a prescription medication approved for adults with unresectable or metastatic melanoma, particularly when the cancer has not responded or ceased responding to PD-1 blocking drugs alone or in combination, and to BRAF inhibitors with or without MEK inhibitors, if the cancer is BRAF mutation positive. Its approval, contingent on response rate, may require confirmation from ongoing studies to ensure continued use.


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