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EU regulator requires secondary cancer risk warning for CAR-T therapies
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EU regulator requires secondary cancer risk warning for CAR-T therapies
Jun 14, 2024 10:42 AM

June 14 (Reuters) - The European health regulator said

on Friday cancer cell therapies known as CAR-T treatments must

include a written warning of an associated risk for secondary

blood cancers in patients who use them and that patients should

be monitored for life.

The European Medicines Agency's (EMA) directive from its

Pharmacovigilance Risk Assessment Committee echoes the one

issued by the U.S. health regulator in April and follows a

five-month safety review.

Manufacturers of CAR-T therapies - a bespoke process in

which patient T-cells are removed, modified to fight cancer and

then reinfused - will now be required to include the information

on their label. Their review found new cancers that begin in a

type of white blood cells called T-cells.

Johnson & Johnson ( JNJ ), Bristol Myers Squibb ( BMY ) and

Gilead Sciences ( GILD ) are among the makers of CAR-T

therapies.

The EMA committee evaluated data on 38 cases of secondary

T-cell cancers in patients who received CAR-T therapy and

identified seven cases where the therapy was involved in disease

development. The cases were reported out of the 42,500 people

who have been treated with the therapy, it said.

The panel found that secondary T-cell cancers have been

reported within weeks and up to several years following

administration of CAR-T, or chimeric antigen receptor T-cell

therapy, medicines.

The EMA panel had announced a safety review in January on

therapies including Bristol's Breyanzi and its partnered therapy

with 2seventy bio, Abecma, J&J and Legend Biotech's ( LEGN )

Carvykti, Novartis' Kymriah, and Gilead's

Tecartus and Yescarta.

Earlier this year, the U.S Food and Drug Administration

imposed its strongest "boxed warning" on CAR-T therapies for

risk of secondary blood cancers and also required lifelong

monitoring for a new cancer.

As part of its review, the FDA found that secondary T-cell

cancers have been reported in conjunction with five of the six

available CAR-T therapies.

Since 2017, six CAR-T cell therapies have been approved

by the FDA, and all are for the treatment of blood cancers,

including lymphomas and some forms of leukemia.

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