A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first treatment that genetically alters a patient’s own cells to fight leukemia, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease.
If the F.D.A. accepts the recommendation, which is likely, the treatment will be the first gene therapy to reach the market. Others are expected: Researchers and drug companies have been engaged in intense competition for decades to reach this milestone. Novartis is now poised to be the first, and it is working on similar types of treatments for another type of leukemia, as well as multiple myeloma and an aggressive brain tumor.
Image: Emily Whitehead, 12, with her parents Tom and Kari Whitehead, on Tuesday in Washington, D.C. The family appeared at a hearing for the F.D.A. about a new treatment for leukemia. Credit T.J. Kirkpatrick for The New York Times
