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Thursday, Jul 13 2017

Full Issue

'Most Exciting Thing I've Seen In My Lifetime': FDA Panel Approves Groundbreaking Cancer Treatment

Full approval from the agency is expected to follow.

A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient鈥檚 own cells to fight cancer, transforming them into what scientists call 鈥渁 living drug鈥 that powerfully bolsters the immune system to shut down the disease. (Grady, 7/12)

The unanimous recommendation from the聽Oncologic Drugs Advisory Committee聽means the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier. Timothy Cripe, a panel member who is an oncologist with Nationwide Children's Hospital聽in Columbus, Ohio, called the treatment the "most exciting thing I've seen in my lifetime." (McGinley, 7/12)

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 鈥 finding ways to harness the body's own immune system to fight cancer. (Stein, 7/12)

An advisory panel of the FDA voted 10-0 to recommend the approval of tisagenlecleucel, a treatment developed by the pharmaceutical firm Novartis. The treatment requires the extraction of a patient鈥檚 own infection-fighting T-cells, which are then genetically engineered to recognize and fight the cancer cells affecting the patient, and infused back into the bloodstream. (Garver, 7/12)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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