On Thursday, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb & Co.’s (NYSE:BMY) Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL).
Breyanzi is administered as a one-time infusion.
Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy.
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The approval of Breyanzi is based on results from the MZL cohort in the TRANSCEND FL study.
In the third-line plus setting and included in the primary efficacy analysis set, the overall response rate (ORR) was 95.5%.
ORR was defined as the percentage of patients achieving a partial or complete response.
The complete response (CR) rate was 62.1%. The median duration of response (mDOR) was not reached, with 90.1% of responders remaining in response at 24 months.
Breyanzi is broadly covered by commercial and government insurance programs in the U.S. Bristol Myers Squibb offers various programs and resources to address the needs of patients and care partners that support their CAR T cell therapy treatment journey.
European Approval
In March, the European Commission approved Breyanzi for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
In November, the FDA approved Genmab A/S‘ (NASDAQ:GMAB) Epkinly (epcoritamab-bysp) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL).
BMY Price Action: Bristol-Myers Squibb shares were up 0.09% at $51.99 during premarket trading on Friday, according to Benzinga Pro data.
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