FDA approves groundbreaking treatment for advanced melanoma
The Food and Drug Administration on Friday approved a new cancer therapy that could one day transform the way a majority of aggressive and advanced tumors are treated.
The Food and Drug Administration on Friday approved a new cancer therapy that could one day transform the way a majority of aggressive and advanced tumors are treated.
The treatment, called Amtagvi, from Iovance Biotherapeutics, is for metastatic melanoma patients who have already tried and failed other drugs. It’s known as TIL therapy and involves boosting the number of immune cells inside tumors, harnessing their power to fight the cancer.
It’s the first time a cellular therapy has been approved to treat solid tumors. The drug was given a fast-track approval based on the results of a phase 2 clinical trial. The company is conducting a larger phase 3 trial to confirm the treatment’s benefits. The therapy’s list price — the price before insurance and other potential discounts — is $515,000 per patient.
“This is going to be huge,” said Dr. Elizabeth Buchbinder, a senior physician at Dana-Farber Cancer Institute in Boston. Melanoma is “not one of those cancers where there’s like 20 different” possible treatments, she said. “You start running out of options fast.”
Dan Bennett, 59, credits TIL therapy with allowing him to beat the slim odds of long-term survival of stage 4 melanoma. His daughter, Faith Bennett, 29, first noticed a suspicious mole on Bennett's neck in 2011.Courtesy Dan BennettFriday’s approval is only for melanoma, the deadliest form of skin cancer, but experts say it holds promise for treating other solid tumors, which account for 90% of all cancers.
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