FDA approves new therapy for hard-to-treat metastatic melanoma

By Jen Christensen, CNN

(CNN) — On Friday, the US Food and Drug Administration approved a new, first-of-its-kind therapy that could help patients with metastatic melanoma, a rare but deadly form of skin cancer.

The drug, made by the California-based Iovance Biotherapeutics, is approved to treat patients for whom other medicines have failed and the skin cancer is unable to be removed with surgery, or the cancer has spread to other parts of the body.

Amtagvi, as the treatment is called, is the first cellular therapy used to treat this form of solid tumor cancer. The company said the drug will be made in Philadelphia with the capacity to help up to “several thousand patients annually.”

The therapy works by using a person’s own immune cells to fight the cancer. With this treatment, doctors will remove tissue from the patient’s tumors and then take its immune cells and grow them in the lab. Once there are enough immune cells, doctors then give them back to the patient in an infusion and the immune cells go on to overwhelm and destroy the cancer.

Patients only need to receive the treatment once for it to work — and it can work for years, said Dr. Ryan Sullivan, the associate director of the Melanoma Program at Mass General Cancer Center. The center was a site for one of the trials with the new therapy, which was evaluated at several centers around the world.

In the trials, the FDA said that “among the 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. Among patients who were responsive to the 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 a severe low blood count, severe infection and cardiovascular problems.

Other risks associated with the treatment relate to the surgery associated with the treatment and with seven days of intensive chemotherapy that the patient will need before receiving the treatment.

The company says the other side effects can include chills, fever, tiredness, a fast heart rate, diarrhea, fever, rash and hair loss. Most side effects clear up in 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 studies will be needed to show how long the treatment can last.

About 100,640 new melanomas will be diagnosed every year according to the American Cancer Society and more than 8,000 people in the US die from melanoma every year. This cancer makes up only 1% of skin cancer cases, but accounts for many of the deaths related to skin cancer.

“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 treating cancer may be useful to treat other hard-to-fight cancers too.

“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, who treats melanoma patients in Massachusetts, said Friday’s FDA announcement will come as 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.”

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