FDA Looking Into All Approved CAR T Therapies on Risk of Cancer in White Blood Cells

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 [e-mail]

(END) Dow Jones Newswires

November 28, 2023 14:53 ET (19:53 GMT)

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