Europe Approves Bristol Myers' Cell Therapy Breyanzi For Patients With Certain Type Of Blood Cancer

On Friday, the European Commission (EC) approved Bristol Myers Squibb & Co‘s BMY Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

The decision is based on global Phase 2 TRANSCEND FL study results.

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Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 97.1% and a complete response (CR) rate of 94.2%, the study’s primary and key secondary endpoints, respectively.

Responses were rapid, durable, and demonstrated sustained efficacy, with a median time to first response of 0.95 months and 75.7% of patients still in response at 18 months.

Last March, the FDA granted accelerated approval to Breyanzi for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

In May, the FDA granted accelerated approval to Breyanzi for relapsed or refractory follicular lymphoma. 

In November, Bristol Myers Squibb shared preliminary data from a Phase 1 study of CC-97540 (BMS-986353), a CD19-directed CAR T Cell Therapy Manufactured Using a Next-generation Process for severe, refractory autoimmune diseases.

Price Action: BMY stock is down 1.92% at $59.13 at the last check Friday.

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Image: Courtesy of Bristol Myers Squibb