US FDA approves expanded use of Bristol Myers cancer cell therapy
Breyanzi was first approved in 2021 as a second-line treatment for B-cell lymphoma
WASHINGTON (Reuters) – The US health regulator on Wednesday approved the expanded use of Bristol Myers Squibb's cancer cell therapy Breyanzi for the treatment of adults with a type of blood cancer called follicular lymphoma, which 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 US, 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 US 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 per cent of patients who had received at least two prior treatments. Data shows that 97pc 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' Yescarta.
