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May 17, 2024 : The U.S. Food and Drug Administration (FDA) has granted expanded use for Bristol Myers Squibb’s CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel). This regulatory decision represents a significant advancement in the treatment options available for patients battling a specific type of blood cancer.
Previously, Breyanzi was approved for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy. This latest FDA action expands the therapy’s application to encompass patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
Follicular lymphoma is a slow-growing cancer affecting the B-lymphocytes, a type of white blood cell. While often treatable, it can relapse in some patients, necessitating further therapeutic intervention. Breyanzi offers a potential new approach for these patients who have exhausted other treatment options.
The FDA’s decision to expand Breyanzi’s use is based on promising clinical trial data. The Phase II TRANSCEND FL study evaluated the efficacy and safety of Breyanzi in patients with relapsed or refractory follicular lymphoma. The results demonstrated an impressive overall response rate, exceeding 95%, with a complete response rate exceeding 73%. These findings suggest Breyanzi’s potential to induce remission in many patients with this form of lymphoma.
This regulatory approval is a welcome development for patients and the medical community. Breyanzi, a chimeric antigen receptor (CAR) T-cell therapy, represents a groundbreaking approach to cancer treatment. CAR-T therapies genetically modify a patient’s T-cells to recognize and attack specific cancer cells. This personalized approach offers a potentially curative option for patients with aggressive blood cancers.
The expanded use of Breyanzi signifies the progress made in CAR-T cell therapy. As research and development efforts continue, CAR-T therapies have the potential to revolutionize the treatment landscape for a broader range of cancers.
It is important to note that Breyanzi, like any medical treatment, carries potential side effects. Physicians must carefully evaluate the risks and benefits of Breyanzi therapy for each patient.
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