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US FDA approves expanded use of Bristol Myers' cancer cell therapy
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US FDA approves expanded use of Bristol Myers' cancer cell therapy
May 15, 2024 7:21 PM

May 15 (Reuters) - The U.S. health regulator on

Wednesday approved the expanded use of Bristol Myers Squibb's ( BMY )

cancer cell therapy Breyanzi for the treatment of adults

with a type of blood cancer called follicular lymphoma, that has

returned or has not responded to prior treatments.

The Food and Drug Administration's decision marks the fourth

approval for Breyanzi, which can now be used to treat patients

who have received two or more prior lines of therapy.

The approval provides an option with potential for

lasting remission in a one-time infusion and a safety profile

that allows for administration and monitoring in an increasing

number of certified treatment centers in the U.S., said Bryan

Campbell, Bristol Myers' head of commercial cell therapy in a

statement.

Breyanzi was first approved in the United States in 2021 as

a second-line treatment for a type of blood cancer known as

large B-cell lymphoma.

The therapy belongs to a class of drugs known as chimeric

antigen receptor (CAR) T-cell therapies that work by modifying

white blood cells known as T-cells to attack cancer.

Follicular lymphoma is a common type of non-Hodgkin lymphoma

where malignant cancer cells form in the lymph system. Most

patients with follicular lymphoma are aged 50 years and older

when they are diagnosed.

The rate of new cases of non-Hodgkin lymphoma was 18.6 per

100,000 men and women per year, according to U.S. government

data.

Patients with this slow-growing type of cancer also

experience periods of remission and relapse - with the disease

becoming more difficult to treat with each relapse.

Data from a mid-stage study showed that Breyanzi helped in

removing all signs of cancer in 94% of patients who had received

at least two prior treatments. Data shows that 97% of patients

in the study showed signs of the cancer disappearing or

shrinking after treatment with Bristol's therapy.

Bristol expects that additional approval could roughly

double the addressable market for Breyanzi.

The company is working to expand its manufacturing capacity

for its CAR-T therapies - Abecma and Breyanzi - due to

increasing demand.

Other treatment options include cell therapies such as

Novartis' Kymriah and Gilead Sciences' ( GILD )

Yescarta.

(Reporting by Sneha S K and Bhanvi Satija in Bengaluru,

additional reporting by Gnaneshwar Rajan; Editing by Shailesh

Kuber and Varun H K)

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