A new cancer treatment that uses genetically engineered cells from a patient's immune system to attack their cancer easily cleared a new milestone Wednesday.
A Food and Drug Administration pannel unanimously recommended that the agency approve this "living drug" approach for children and young adults who are fighting a common form of leukemia.
The treatment takes cells from a patient's body, modifies the genes, and then reinfuses those modified cells back into the person who has cancer. If the agency approves, it would mark the first time the FDA has approved anything considered to be a "gene therapy product."
The treatment is part of one of the most important developments in cancer research in decades — finding ways to harness the body's own immune system to fight cancer. And while it has generated much hope, there concerns about its safety over the long term (scientists use a virus to make the genetic changes in the T cells, raising fears about possible long-term side effects) and cost (some industry analysts project it will cost $500,000 per infusion).
Even so, several panel members were unusually enthusiastic in explaining their 10-0 vote recommending approval.
The FDA doesn't have to follow the committee's recommendation but usually does.