March 14 (Reuters) - The U.S. Food and Drug

Administration on Thursday expanded the use of Bristol Myers

Squibb's ( BMY ) cell therapy, Breyanzi, for a type of

slow-growing blood cancer, marking the third approval for the

treatment.

Breyanzi was initially approved in the United States in

February 2021 to treat a type of blood cancer known as large

B-cell lymphoma in adult patients whose disease has returned or

stopped responding to treatment.

With the FDA's decision, the therapy is now approved to

treat patients with chronic lymphocytic leukemia or small

lymphocytic lymphoma.

The disease is characterized by increased production of

abnormal white blood cells that have difficulty fighting

infections. These faulty cells can be found in the bone marrow

or lymph nodes.

The therapy brought in $364 million in revenue for Bristol

in 2023.

Sales of Breyanzi are expected to reach $2 billion by 2030,

according to LSEG estimates, helping it fill in some of the

expected gap when top-sellers such as cancer drug Opdivo lose

patent protection.

‍The wholesale list price of the therapy is $487,477, a

company spokesperson said in an emailed statement.

Like other CAR-T therapies, Breyanzi comes with a serious

warning about the risk of secondary malignancies, or cancers, in

patients who use the drug.

The warning was added to the label information for similar

therapies earlier this year after reports of T-cell cancers

that occurred after treatment with CAR-T.

Breyanzi is also under review for use in patients with

two other types of cancers that affect disease-fighting white

blood cells, known as follicular lymphoma and mantle cell

lymphoma.

A decision from the U.S. FDA is expected by May.

The current approval was based on an early-to-mid stage

study in which the therapy showed a complete disappearance of

tumors in 18.4% of patients of either refractory chronic

lymphocytic leukemia or small lymphocytic lymphoma.

The rate of new cases for both cancers is 4.4% per 100,000

men and women in the United States per year, according to

government data.