FDA Looking Into All Approved CAR T Therapies on Risk of Cancer in White Blood Cells
November 28 2023 - 3:08PM
Dow Jones News
By Zaeem Shoaib
The U.S. Food and Drug Administration is investigating certain
CAR T cancer therapies based on reports that they might cause a
type of white blood cell to become cancerous in patients who
received the treatment.
CAR T cell immunotherapies work by manipulating a patient's own
disease-fighting white blood cells called T cells and then infusing
them back into the body to fight cancer.
The FDA said that the risk of the T cells becoming cancerous
applies to all currently approved BCMA-directed and CD19-directed
CAR T cell immunotherapies.
Such currently approved therapies include Bristol-Myers Squibb's
Abecma and Breyanzi; Johnson & Johnson companies Janssen
Biotech and Legend Biotech's Carvykti; Novartis's Kymriah; and
Gilead Sciences unit Kite Pharma's Tecartus and Yescarta.
The FDA said the approvals for these drugs included a
requirement to conduct 15-year long-term followup observational
safety studies to assess the long-term safety and the risk of
secondary cancers emerging after treatment.
The regulator is evaluating the need for action and is
investigating the risk of T cell cancer after treatment with
serious outcomes, including hospitalization and death. However, the
FDA said that the overall benefits of these products continue to
outweigh their potential risks for their approved uses.
Write to Zaeem Shoaib at zaeem.shoaib@wsj.com
(END) Dow Jones Newswires
November 28, 2023 14:53 ET (19:53 GMT)
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