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The drug made by California -based Iovance Biotherapeutics is approved to treat patients for whom other medicines have failed and skin cancer is unable to remove with surgery, or cancer has spread to other parts of the body.
Amtagvi, as called treatment, is the first cellular therapy used to treat this form of solid tumor cancer. The company said that the drug will be made in Philadelphia with the ability to help several thousand patients to do annuals “.
Medical works using a person’s own immune cells to fight cancer. With this treatment, the doctor will remove the tissue from the patient’s tumor and then take its immune cells and develop them in the laboratory. Once when there are enough immune cells, the doctors give them back to the patient in a infusion and immune cells go to destroy and destroy cancer.
Patients only need to get treatment once to work – and it can work for years, Dr. Dr. Associate Director of Melanoma Program at Mass General Cancer Center. Ryan Sulivan said. The Center was a site for one of the tests with new therapy, which was evaluated in many centers around the world.
In trials, the FDA stated that “in 73 patients treated with MTAGI at recommended doses, the objective response rate was 31.5%, with three (4.1%) patients with full reaction and 20 (27.4%) with a partial reaction with patients. Respectively.”
The FDA stated that treatment would warns a boxing to inform patients that treatment can cause a severe low blood count, severe infection and cardiovascular problems.
Other risk associated with treatment relates to surgery associated with treatment and with intensive chemotherapy of seven days that the patient will need before receiving treatment.
The company says other side effects may include chills, fever, fatigue, a rapid heart rate, diarrhea, fever, rash and hair loss. Most side effects are clear in the first few weeks. Despite the risks, doctors say that benefits for patients can be very high.
“It is not just that the patients will live for an additional two or three weeks, that these patients can be cured with treatment, or very minimal, they may have controlled the disease and will last two, three, four years and then,” Sulivan said, who is also an Associate Professor at Harvard Medical School. “It is really exciting.”
This will require long -term follow -up studies to show how long the treatment can last.
According to the American Cancer Society, about 100,640 new melanoma will be diagnosed every year and more than 8,000 people in the US die of melanoma every year. This cancer makes only 1% of skin cancer cases, but is responsible for many deaths related to skin cancer.
“Melanoma is a life-threatening cancer that can have a destructive effect on affected persons, with a significant risk of metastasizing and spreading in other areas of the body,” Dr. Nicole Wordun said, Director of the office of medical products at the center of biological evaluation and research. “Today’s acceptance reflects the dedication and commitment of FDA for the development of innovative, safe and effective treatment options for cancer patients.”
Research suggests that this approach to treat cancer can also be useful for treating other hard-to-fight cancer.
Interim Chief Executive Officer and President of Iovance Dr. Frederick Vogt said, “Given the important unmatched needs in the advanced Melanoma community, we are proud to offer a personal, one -time medical option for these patients.” “We are continuing our development efforts to address additional UNMET medical requirements in solid tumor cancer patients, allowing our novel cell therapy to more patients with melanoma and other types of cancer.”
Sulivan, who treated Melanoma patients at Massachusetts, said that Friday’s FDA announcement will come as good news.
“While patients with melanoma have much more treatment options than 15 years ago, we still have many of our patients who are diagnosed with metastatic melanoma dying,” Sulivan said. “This is another option, especially an option in the population of patients, where our standard remedies have failed them.”
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