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FDA approved BMS' Breyanzi for relapsed or refractory follicular lymphoma | iPharmaCenter

Bristol Myers Squibb's innovative CAR T Cell Therapy, Breyanzi, has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory follicular lymphoma (FL) in adult patients who have undergone two or more prior lines of systemic therapy.

This accelerated approval is based on response rate and duration of response, with continued approval contingent upon confirmation of clinical benefit in further trials.


Breyanzi is now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell Lymphomas as a recommended therapy for third-line and subsequent treatment of relapsed or refractory FL.


In the treatment of relapsed or refractory FL, Breyanzi is administered as a single infusion, containing CAR-positive viable T cells.


Historically, FL has presented a challenge for treatment, often leading to relapse despite initial therapy. The Phase 2 TRANSCEND FL study, involving the largest group of patients with relapsed or refractory FL in a CAR T cell therapy trial, demonstrated promising results.


In the primary efficacy analysis, Breyanzi showed an overall response rate (ORR) of 95.7%, with a complete response (CR) rate of 73.4%. Responses were rapid and durable, with many patients maintaining response at 12 and 18 months.


Safety data from clinical trials indicated a consistent safety profile for Breyanzi, with manageable rates of cytokine release syndrome (CRS) and neurologic events (NEs). This safety profile allows for outpatient treatment and management of patients, offering flexibility in care settings.


Breyanzi's approval represents a significant advancement in the treatment landscape for relapsed or refractory FL, providing patients with a personalized therapy option that offers durable responses and a manageable safety profile.

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