The most dangerous type of skin cancer.. Food and Drug Administration approves a new treatment for metastatic melanoma

Dubai, United Arab Emirates - On Friday, the US Food and Drug Administration approved a new treatment considered the first of its kind that can help patients suffering from metastatic melanoma, a rare and deadly form of skin cancer. The drug, made by California-based Iovance Biotherapeutics, is approved to treat patients in whom other drugs have failed and who cannot remove the skin cancer with surgery, or whose cancer has spread to other parts of the body.

Amtagvi is the first cell therapy used to treat this type of solid tumor cancer. The company explained that the drug will be manufactured in Philadelphia, with the ability to help up to "several thousand patients annually."

The treatment works using a person's own immune cells to fight cancer. Through this treatment, doctors will remove tissue from the patient's tumors and then take his immune cells and culture them in the laboratory.

Once there are enough immune cells, doctors return them to the patient through injections, and the immune cells continue to overcome and destroy the cancer. Patients need to receive the treatment only once, and the effect of this treatment may last for years, according to Dr. Ryan Sullivan, associate director of the skin cancer program at the Comprehensive General Cancer Center.

The center was the site of a trial of the new treatment, which has been evaluated in several centers around the world. During the trials, the FDA noted that “among 73 patients treated with Amtagvi at the recommended dose, the objective response rate was 31.5%, including three (4.1%) patients who had a complete response, and 20 (27.4%) patients who had a partial response.

Among patients who responded to treatment, 56.5%, 47.8%, and 43.5% continued to maintain responses without tumor progression or death for 6 months, 9 months, and 12 months, respectively. The US Food and Drug Administration confirmed that the treatment will carry a warning to patients stating that the treatment can cause a severe drop in blood cell counts, severe infection, and cardiovascular problems.

Other treatment risks are related to the surgery associated with the treatment and the 7 days of intensive chemotherapy that the patient will need before receiving the treatment. The company indicated that other side effects may include chills, fever, fatigue, rapid heartbeat, diarrhea, skin rash, and hair loss.

Most side effects disappear within the first few weeks. Despite the risks, doctors say the benefits to patients could be enormous.

“With this treatment, not only will patients live an additional two or three weeks, but these patients may be cured with the treatment, or at a minimum perhaps control the disease for two, three, four years or more,” said Sullivan, who is also an associate professor at Harvard Medical School. “Long-term follow-up studies will be needed to show how long the treatment can be continued.”

About 100,640 new cases of melanoma are diagnosed annually, according to the American Cancer Society, and more than 8,000 people in the United States die from melanoma each year. This cancer represents only 1% of skin cancer cases, but it is responsible for many skin cancer-related deaths.

Dr. Nicole Verdun, Director of the Office of Therapeutic Products at the Center for Biological Evaluation and Research, explained, “Melanoma is a life-threatening cancer that can have devastating effects in individuals with it, with a high risk of it spreading to other areas of the body.” She added: “The approval of the new treatment reflects the FDA’s dedication and commitment to developing innovative, safe and effective treatment options for cancer patients.”

Research suggests that this approach to cancer treatment may be useful for treating other hard-to-fight cancers as well.