June 27 (Reuters) - The U.S. Food and Drug

Administration said on Friday it had eliminated risk evaluation

and mitigation strategies (REMS), a safety program to protect

patients from risky drugs, for currently approved CAR-T cell

immunotherapies.

REMS is required by the FDA to ensure a drug's benefits

outweigh its risks by managing serious safety concerns.

The FDA said risks linked to CAR-T cell therapies can be

effectively communicated through existing labeling, including

boxed warnings for cytokine release syndrome and neurological

toxicities, and medication guides.

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

Breyanzi and its partnered therapy Abecma with 2seventy bio

, Johnson & Johnson's ( JNJ ) unit Janssen and Legend

Biotech's ( LEGN ) Carvykti, Novartis AG's Kymriah, and

Gilead Sciences' ( GILD ) unit Kite's Tecartus and Yescarta.

Bristol-Myers Squibb ( BMY ) and Gilead Sciences ( GILD ) did not

immediately respond to Reuters' requests for comment.

These are gene therapies that are currently approved to

treat blood cancers, such as multiple myeloma and certain types

of leukemia and lymphoma, the health regulator said.

CAR-T 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.

In January 2024, the FDA

asked several drugmakers

to add a serious warning on the label of their cancer

therapies that use CAR-T technology after reports of T-cell

malignancies and adverse events identified since approval.

The FDA earlier said the risk of T-cell malignancies

including leukemia and lymphoma applies to all therapies in the

class and can lead to hospitalization and death.