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 Abecma, 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.

Gilead said it has updated the labels for Yescarta and

Tecartus reflect the FDA's removal of the REMS requirement.

"We are pleased that they will help lessen the burden on

HCPs and patients, enabling more people to receive these

potentially curative treatments," Gilead added.

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.

"CAR T cell therapy is a transformational, potentially

life-saving option for patients living with blood cancers, and

we are working to challenge current practices, assumptions and

barriers that limit access," said Lynelle Hoch, president of

Cell Therapy Organization at Bristol-Myers Squibb ( BMY ).

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.