Breakthrough Melanoma Treatment: FDA Approves Amtagvi

By iMedix
Updated 2024-03-22 10:15:23 | Published 2024-02-19 23:32:49
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February 20, 2024 marks a momentous day in medical history. The FDA (U.S. Food and Drug Administration) approved Amtagvi, the first-ever cellular therapy for the treatment of metastatic melanoma that has not responded to other therapies.

Amtagvi is a personalized treatment that relies on harnessing the patient's own immune system to combat cancer.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “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.”

How Amtagvi works:

  1. Extraction: A small piece of tissue is taken from the patient's tumor.
  2. Multiplication: T-cells – immune cells capable of recognizing and destroying cancer cells – are extracted from the tissue and multiplied in a lab over 22 days.
  3. Preparation: The patient undergoes chemotherapy to “make space” for the “super soldiers” – the multiplied T-cells.
  4. Infusion: The multiplied T-cells (TIL cells) are infused back into the patient's body.
  5. Attack: TIL cells recognize and attack cancer cells, helping the body fight the disease.


  • 31.5% of patients who received Amtagvi experienced tumor shrinkage.
  • 56.5% of patients who had tumor shrinkage had no disease progression or death at 6 months.
  • 47.8% of patients had no disease progression or death at 9 months.
  • 43.5% of patients had no disease progression or death at 12 months.

Amtagvi is not a cure, but it is a major step forward in the treatment of melanoma.

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.

Advantages of Amtagvi:

  • Personalized approach: The therapy uses the patient's own T-cells, which ensures high precision and effectiveness.
  • Long-term effect: TIL cells can remain in the body for decades, providing long-term protection against relapse.
  • New hope: Amtagvi offers a chance for patients who have not responded to other treatments.

Disadvantages of Amtagvi:

  • Risk of side effects: The therapy can cause severe side effects, such as low white blood cell count, infections, heart problems, and lung problems.
  • High cost: The treatment costs $515,000 USD per patient.
  • Long process: The whole process takes about eight weeks.

Amtagvi is a breakthrough in melanoma treatment that has the potential to change the lives of many people.

In the future, TIL therapy could be used to treat other types of cancer.

This news is a significant event in the world of medicine. It opens up new possibilities for cancer treatment and offers hope to millions of people.

Additional information:

    • FDA Approves TIL Therapy for Metastatic Melanoma: Link
    • Melanoma Overview – A Dangerous Skin Cancer: Link
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