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US FDA mandates label updates on CAR-T cancer therapies
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US FDA mandates label updates on CAR-T cancer therapies
Apr 18, 2024 4:15 PM

April 18 (Reuters) - The U.S. Food and Drug

Administration said on Thursday cancer therapies that use CAR-T

technology will require changes to the so-called "boxed warning"

to highlight the serious risk of T-cell blood cancer in patients

who use these therapies.

The health regulor has required related updates to other

sections of the label such as warnings and precautions,

postmarketing experience, patient counseling information and

medication guide.

The agency said patients and clinical trial participants

receiving treatment with these products should be monitored

life-long for secondary malignancies and the manufacturer should

be notified in the event of a new malignancy.

In January, the FDA asked a host of drugmakers including

Gilead Sciences ( GILD ), Johnson & Johnson ( JNJ ) and Novartis

to add a boxed warning to their CAR-T cancer therapies,

as it received reports of patients developing a type of T-cell

blood cancer after being treated with them.

The other cancer therapies include Bristol Myers Squibb's ( BMY )

Breyanzi and its therapy, Abecma, with partner 2seventy

bio, J&J unit Janssen and Legend Biotech's ( LEGN )

Carvykti, Novartis AG's Kymriah, and Gilead unit Kite's

Tecartus and Yescarta.

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