US FDA mandates label updates on CAR-T cancer therapies
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 [April 19, 2024]
(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 regulator 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, Johnson & Johnson 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.
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The headquarters of the U.S. Food and Drug Administration (FDA) is
shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason
Reed//File Photo
 The other cancer therapies include
Bristol Myers Squibb's Breyanzi and its therapy, Abecma, with
partner 2seventy bio, J&J unit Janssen and Legend Biotech's Carvykti,
Novartis AG's Kymriah, and Gilead unit Kite's Tecartus and Yescarta.
(Reporting by Christy Santhosh in Bengaluru;
Editing by Shailesh Kuber)
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