Bristol Myers Squibb (BMY) announced that the U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion.
With this latest approval, Breyanzi becomes the only CAR T cell therapy approved by the FDA for five different cancer types, the most of any CD19-directed CAR T cell therapy.
In the U.S., Breyanzi is approved for the treatment of R/R large B-cell lymphoma (LBCL) after at least one prior line of therapy. It has also received accelerated approval for R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy, as well as approval for R/R follicular lymphoma (FL) after two or more prior lines of systemic therapy, and R/R mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy.
Breyanzi's approvals extend globally. It is authorized in Japan, the European Union (EU), Switzerland, Israel, the United Kingdom (UK), and Canada for the treatment of R/R LBCL after at least one prior line of therapy. In Japan, it is also approved for patients with R/R high-risk FL after one prior line of systemic therapy, and for R/R FL after two or more lines of systemic therapy. In the EU, Switzerland, Israel, and the UK, Breyanzi is approved for R/R FL after two or more lines of systemic therapy. Additionally, in the EU and Israel, it is approved for R/R MCL after at least two lines of systemic therapy, including treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
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