United States: The US Food and Drug Administration (FDA) on Friday granted approval for this new and unique type of treatment which is the first of its kind. The approach therapy is there to provide supportive treatment for patients bearing metastatic melanoma, a rarely-occurring deadly skin cancer.
More about the new treatment
The drug, manufactured by Iovance Biotherapeutics in California, is used for the treatment of patients in whom existing medicines have failed and melanoma cannot be removed by surgery due to the extended presence of melanoma in other organs.
Amtavir, as the treatment is called, is the first cellular therapy aimed at this type of solid cancer tissue tumor. The company said the drug will be manufactured in Philadelphia, with the capacity to help up to several thousand patients per year, as CNN Health reported
How does the new treatment work?
Regarding therapy, the person’s own immune cells are being used to kill cancer cells. Furthermore, the physicians will remove the tumor tissue from the body of the patient, after that they will isolate the immune cells irrespective of the implication of the patient and then grow them in the laboratory.
At this point, when the cancer cells are destroyed by the immune cells, immune cells are given back to the patient in a transfusion and they continue with their activity of killing and destroying more cancer cells.
The therapy must be administered only once for it to work, and it may keep working for years said Dr. Ryan Sullivan, the associate director of the Melanoma Program at Mass General Cancer Center. One of the trials for the new therapy took place at the center, which was 1 of the several testing centers worldwide, CNN Health reported.
What does the FDA have to say?
In the trials, the FDA was of the opinion 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 informed that the treatment will bear a boxed warning label that will alert patients that the treatment can cause severe low blood count, severe infection, and cardiovascular issues.
Risks associated with the treatment
Other risks related to the treatment include the associated surgery and seven days of intensive chemotherapy before receiving the treatment.
According to the company, these other side effects can include chills, fever, tiredness, rapid heartbeat, diarrhea, fever, rashes, and hair loss. Most side effects go away in the first 4 weeks. While the risks for the patients are rather questionable, doctors claim that for a patient, the benefits may be tremendous.
As CNN Health reported, Sullivan, who is also an associate professor at Harvard Medical School said, “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, ” and, “That’s really exciting.”
Long-term study is needed – Experts
Long-term follow-up studies need to be done to show how long the treatment can take effect.
The American Cancer Society estimates that about 100,640 melanoma will be detected yearly, and more than 8,000 people die from Melanoma annually. This kind of cancer covers 1% of skin cancer cases but accounts for the major part of deaths related to skin cancer.
In response to this, Dr. Nicole Verdun, the director of the Office of Therapeutic Products in the Center of Biologics Evaluation and Research, said, “Melanoma, being a life-threatening cancer, can have catastrophic effects on the individual, with a probability of local invasion and metastasis into other body parts.”
Adding further, Verdun said, “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe, and effective treatment options for cancer patients.”
The treatment might help cure other deadly cancers too
Studies show this may be an efficient strategy in fighting other difficult-to-treat cancers.
Dr. Frederick Vogt, interim chief executive officer and president of Iovance said, “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients,” as CNN Health reported.
Vogt added further, “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.”
On Friday, Sullivan who treats patients with melanoma in Massachusetts confirmed the FDA’s announcement as great news.
Sullivan said, “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,” and, “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.”