FDA approves new treatment for difficult-to-treat metastatic melanoma

A new treatment for metastatic melanoma, a rare but fatal type of skin cancer, was authorized by the US Food and Drug Administration on Friday.

Produced by Iovance Biotherapeutics, a California-based company, the medication is licensed for the treatment of patients whose skin cancer has progressed to other places of the body or cannot be surgically removed.

This type of solid tumor cancer is being treated with a cellular therapy for the first time, termed Amtagvi. According to the business, the drug, which has the potential to help up to “several thousand patients annually,” will be produced in Philadelphia.

This therapy uses a person’s own immune cells to fight cancer. In this treatment, doctors remove tissue from a patient’s tumor, harvest immune cells from it, and grow them in a laboratory. Once there are enough immune cells, the doctor puts them back into the patient through an IV, and the immune cells overwhelm and destroy the cancer.

Patients only need one treatment to see results, and the results can last for years, he said. said Ryan Sullivan, deputy director of the melanoma program at Massachusetts Comprehensive Cancer Center. This center is where he conducted one of the trials for a new treatment that was evaluated at several centers around the world.

“The objective response rate was 31.5% among the 73 patients treated with Amtagvi at the recommended dose, including three (4.1%) patients with a complete response and 20 (27.4%) patients with a partial response,” the FDA stated in the trials. At six, nine, and twelve months, respectively, 56.5%, 47.8%, and 43.5% of the patients who responded to the medication maintained their responses without tumor progression or death.

The FDA said the treatment will come with a warning label informing patients that it can cause serious bleeding, serious infections and cardiovascular disease.

Other risks associated with treatment are related to the surgery involved and the 7 days of intensive chemotherapy that patients require prior to treatment.

The company says other side effects may include chills, fever, fatigue, increased heart rate, diarrhea, fever, rash and hair loss. Most side effects subside within the first few weeks. Despite the risks, doctors say the benefits for patients could be enormous.

“With this, it’s not just that patients will live an extra two or three weeks, it’s that these patients may be cured with the treatment, or at the very least, they may have controlled the disease and that will last for two, three, four years and beyond,” said Sullivan, who is also an associate professor at Harvard Medical School said. “That’s really exciting.”

Long-term follow-up is required to show how long treatment can continue.

According to the American Cancer Society, approximately 100,640 people are newly diagnosed with melanoma each year in the United States, and more than 8,000 people die from melanoma each year. Although this cancer accounts for only 1% of skin cancer cases, it is responsible for many skin cancer-related deaths.

“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 Dr. Nicole Verdun, director of the Office of Therapeutic Products in the Center of Biologics Evaluation and Research. “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”

Research suggests that this approach to cancer treatment may also be useful in treating other difficult-to-treat cancers.

“Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients,” said Dr. Frederick Vogt, interim chief executive officer and president of Iovance. “We are continuing 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 said in the presentation. The FDA on Friday will be good news.

“While patients with melanoma have a lot more treatment options than they had 15 years ago, we still have a lot of our patients who are diagnosed with metastatic melanoma dying,” Sullivan said. “It’s a very good day to have another option, particularly an option in a population of patients where our standard therapies have failed them.”

Research suggests that this approach to cancer treatment may also be useful in treating other difficult-to-treat cancers.

Sullivan said in the presentation. The FDA on Friday will be good news.