Ivans Biotherapeutics,
AMTAGVI (lifileucel) product packaging is seen in the photo in this handout from Iovance Biotherapeutics.
CNN
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On Friday, the U.S. Food and Drug Administration approved a new, first-of-its-kind treatment that can help patients with metastatic melanoma, a rare but deadly skin cancer.
Manufactured by California-based Ivans Biotherapeutics, the drug is recommended for patients whose skin cancer cannot be removed surgically because other drugs have not worked, or whose cancer has spread to other parts of the body. approved for the treatment of
This treatment, called Amtagvy, is the first cell therapy used to treat this form of solid tumor cancer. The company said the drug will be manufactured in Philadelphia and has the capacity to help “thousands of patients annually.”
This therapy works by using a person's own immune cells to fight cancer. In this treatment, doctors remove tissue from a patient's tumor, harvest the immune cells, and grow them in a laboratory. Once enough immune cells are obtained, doctors give them back to the patient via an intravenous drip. The immune cells then continue to overwhelm and destroy the cancer.
Dr. Ryan Sullivan, associate director of the Melanoma Program at Massachusetts Comprehensive Cancer Center, said patients only need one treatment to see results, which last for years. This center was where he conducted one of his trials of new treatments that were evaluated at several centers around the world.
In this study, the FDA stated, “Of the 73 patients treated with amtagvy at the recommended dose, the objective response rate was 31.5%, including 3 patients (4.1%) who had a complete response, and 3 patients (4.1%) who had a partial response. There were 20 patients (27.4%) who were able to obtain this. response. Of the patients who responded to treatment, 56.5%, 47.8%, and 43.5% continued to respond without tumor progression or death at 6, 9, and 12 months, respectively. ”
The FDA said a boxed warning will appear to inform patients that the treatment can cause severe cytopenias, severe infections, and cardiovascular problems.
Other risks associated with the treatment are related to the surgery involved and the seven days of intensive chemotherapy that patients are required to undergo before undergoing treatment.
Other side effects may include chills, fever, fatigue, increased heart rate, diarrhea, fever, rash and hair loss, the company said. Most side effects subside within the first few weeks. Despite the risks, doctors say the benefits for patients could be enormous.
“Not only does this extend patients' lives by two to three weeks, but it also means that these patients can be cured or at least have their disease under control for two to three weeks.”4 Sullivan, who is also an associate professor at Harvard Medical School, said. “It's really exciting.”
Long-term follow-up is needed to show how long treatment can continue.
According to the American Cancer Society, approximately 100,640 people are newly diagnosed with melanoma each year, and more than 8,000 people die from melanoma each year in the United States. Although this cancer accounts for only 1% of skin cancer cases, it accounts for the majority of skin cancer deaths.
“Melanoma is a life-threatening cancer that can have a devastating impact on those affected and carries a significant risk of metastasis and spread to other areas of the body,” said Dr. said Dr. Nicole Berdan. Biologics evaluation and research. “Today's approval reflects FDA's dedication and commitment to developing innovative, safe and effective treatments for cancer patients.”
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Research shows that this cancer treatment approach may also be useful in treating other difficult-to-treat cancers.
Dr. Frederic Vogt, Interim Chief Executive Officer and President of Ivans, said: “We continue our development efforts to address additional unmet medical needs in patients with solid tumors, making our novel cell therapies available to more patients with melanoma and other cancer types. ”
Sullivan, who treats melanoma patients in Massachusetts, said Friday's FDA announcement will be good news.
“Melanoma patients have far more treatment options than they did 15 years ago, but many patients still die from metastatic melanoma,” Professor Sullivan said. “It's a very good day to have other options, especially options for patient populations where standard treatments have not worked.”
