Wednesday, the FDA granted accelerated approval to Bristol Myers Squibb Co’s BMY Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for relapsed or refractory follicular lymphoma.
This indication is approved under accelerated approval based on response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
In April, following an investigation announced in November last year, the FDA said it would now require boxed warnings—the highest safety-related caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies.
Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory follicular lymphoma.
In relapsed or refractory follicular lymphoma, Breyanzi is delivered as a one-time infusion with a single dose containing 90 to 110 x 10 power 6 CAR-positive viable T cells.
The Phase 2 TRANSCEND FL study included the largest primary analysis set of patients with relapsed or refractory follicular lymphoma of a clinical trial evaluating a CAR T cell therapy in this patient population.
95.7% of patients responded to Breyanzi in the TRANSCEND FL trial.
Breyanzi provided sustained clinical benefit with a median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months.
Read Next: Bristol Myers Squibb Swings To Quarterly Loss, After String Of Multi-Billion Acquisitions.
Price Action: BMY shares are down 1.38% at $43.94 at last check Thursday.
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