The AMTAGVI (lifileucel) product packaging is seen in this photograph from Iovance Biotherapeutics
The medicine, made by the California-based company Iovance BiotherapeuticsIt is approved to treat patients in whom other medications have failed and the skin cancer cannot be removed with surgery, or the cancer has spread to other parts of the body.
Amtagvi, As the treatment is called, it is the first cell therapy used to treat this form of solid tumor cancer. He the company said the drug will be manufactured in Philadelphia and will have the capacity to help up to “several thousand patients a year.”
The therapy works by using a person’s own immune cells to fight cancer. With this treatment, doctors will remove tissue from the patient’s tumors and then take their immune cells and grow them in the laboratory. Once there are enough immune cells, doctors give them back to the patient in an infusion. and immune cells continue to overwhelm and destroy the cancer.
Patients only need to receive the treatment once for it to work, and it can work for years, he said. Dr. Ryan Sullivan, associate director of the Melanoma Program at Mass General Cancer Center. The center hosted one of the trials of the new therapy, which was evaluated in several centers around the world.
In the trials, the FDA said that “among 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. answer. Among patients who responded to treatment, 56.5%, 47.8% and 43.5% continued to maintain responses without tumor progression or death at six, nine and 12 months, respectively.
The FDA said the treatment will carry a boxed warning to inform patients that the treatment can cause serious low blood counts, serious infection and cardiovascular problems.
Other risks associated with the treatment relate to the surgery associated with the treatment and the seven days of intensive chemotherapy that the patient will need before receiving the treatment.
The company says other side effects may include chills, fever, tiredness, rapid heart rate, diarrhea, fever, rash and hair loss. Most side effects go away within the first few weeks. Despite the risks, doctors say the benefits for patients could be enormous.
“With this, it is not only that patients live two or three weeks longer, it is that these patients can be cured with treatment, or at least they can have the disease under control and that will last two, three, four years and more,” said Sullivan. , who is also an associate professor at Harvard Medical School. “That’s really exciting.”
Long-term follow-up studies will be needed to show how long treatment can last.
About 100,640 new melanomas will be diagnosed each year, according to the American Cancer Society and more than 8,000 people in the US die from melanoma each year. This cancer accounts for only 1% of skin cancer cases, but accounts for many skin-related deaths. skin cancer.
“Melanoma is a life-threatening cancer that can cause devastating impacts on affected individuals, with a significant risk of metastasizing and spreading to other areas of the body,” said Dr. Nicole Verdun, director of the Center for Therapeutic Products Office. Evaluation and Research of Biological Products. “Today’s approval reflects the FDA’s dedication and commitment to developing innovative, safe and effective treatment options for cancer patients.”
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Research suggests that this approach to treating cancer may also be useful in treating other hard-to-fight cancers.
“Given the significant unmet needs in the advanced melanoma community, we are proud to offer a unique, personalized therapeutic option for these patients,” said Dr. Frederick Vogt, interim CEO and president of Iovance. “We continue 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.”
Sullivan, who treats melanoma patients in Massachusetts, said Friday’s FDA announcement will be good news.
“While melanoma patients have many more treatment options than 15 years ago, many of our patients who are diagnosed with metastatic melanoma still die,” Sullivan said. “It’s a very good day to have another option, particularly an option in a patient population where our standard therapies have not worked.”