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Reuters


US FDA REQUIRES 'BOXED WARNING' FOR CAR-T CANCER THERAPIES

Reuters
Mon, January 22, 2024 at 8:20 PM EST·2 min read
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FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) -The U.S. health regulator said on Monday companies will be required
to add a serious warning on the prescribing information for cancer therapies
known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others.

Last November, the U.S Food and Drug Administration said it had received reports
of patients developing a type of T-cell blood cancer after being treated with
genetically modified cells known as chimeric antigen receptor T-cell therapies
or CAR-T.

The other cancer therapies include Bristol Myers Squibb's Breyanzi and its
partnered therapy, Abecma, with 2seventy bio, J&J unit Janssen and Legend
Biotech's Carvykti, Novartis AG Kymriah, and Gilead unit Kite's Tecartus and
Yescarta.



The treatment generally involves extracting disease-fighting white blood cells
known as T-cells from a patient, re-engineering them to attack cancer and
infusing them back into the body.

The so-called boxed warnings are the strictest warnings issued by the FDA
regarding the potential serious side effect from the use of a drug.

Since 2017, six CAR-T cell therapies have been approved by the FDA, and all are
for the treatment of blood cancers, including lymphoma and some forms of
leukemia.

The FDA said in its letters to the companies on Monday that since the approval
of the therapies, it had identified adverse events and clinical trial reports
describing T-cell malignancies following the treatment.

The health regulator said it considered the risk of T-cell malignancy, which
refers to a group of blood disorders including lymphoma and leukemia, resulting
in hospitalization and death, to be applicable to all therapies in the category.

Gilead Sciences, Johnson & Johnson, Novartis, Bristol Myers Squibb, 2seventy bio
and Legend Biotech did not immediately respond to Reuters' request for comments.

(Reporting by Gnaneshwar Rajan in Bengaluru; Editing by Sherry Jacob-Phillips)

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