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FDA OKs New Indications for Cell Therapy – Breyanzi

………. catching up on FDA approvals

The FDA has granted expanded indications for a therapy initially approved in 2021 adding to the rapidly growing toolkit of cell and gene therapies that are remapping the way patients with a broad range of diseases are being treated.

The FDA approved Breyanzi (lisocabtagene maraleucel; liso-cel) from Bristol Myers Squibb, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. 

Breyanzi’s approval is based on response rate and duration of response confirmatory trial(s).  It carries a Black Box Warning that include  cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies. Patients with CLL or SLL saw a complete response (CR) and an overall response rate (ORR) of 42.9% during trials. CLL and SLL are among the most common types of B-cell lymphoma.

Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.

Breyanzi’s list price is $410,300 and has faced stiff competition from two competitors, Yescarta and Kymriah.

Is this term in your pharmaceutical vocabulary?…… CAR-T

CAR-T stands for chimeric antigen receptor T cell (CAR-T) therapy in which T-cells are extracted from a patient’s white blood cells and genetically modified in special facilities to target a specific protein that binds to cancer cells. The modified cells are then infused in the patient.


U.S. FDA Approves Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

CLICK HERE to access the press release


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……. catching up on FDA approvals The FDA recently approved another tocilizumab biosimilar, Tyenne (tocilizumab-aazg) from Fresenius Kabi, indicated for Rheumatoid arthritis, Giant cell arteritis,

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