Bristol-Myers Squibb's CD19-directed CAR T therapy, Breyanzi, has received FDA approval to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), types of non-Hodgkin lymphomas.
The therapy is a one-time infusion of CAR-positive viable T-cells, personalized for each patient. It is specifically for patients who have undergone at least two prior treatment regimens. Breyanzi's key features include its ability to generate deep and durable responses, efficacy in patients who have previously had no standard of care, and an established safety profile.
Analyst QuickTake: Breyanzi is not a new name in the market and has been available since the FDA approved it in February 2021 for treating relapsed or refractory large B-cell lymphoma in adults, after two or more lines of systemic therapy. In June 2022, the FDA promoted Breyanzi enabling it to be used after one line of therapy. The drug has a current price of USD 487,477, rising from the original price tag of USD 410,300. The latest approval is a testament to the capabilities and potential of Breyanzi in treating various disease indications.
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