FDA Expands Approval For Bristol Myers Squibb's Breyanzi, Making CAR T Cell Therapy Available For Broadest Range Of B-Cell Malignancies

On Thursday, the FDA approved 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 mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy.

This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies.

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

Earlier this month, the agency granted accelerated approval to Breyanzi for relapsed or refractory follicular lymphoma. 

In relapsed or refractory MCL, Breyanzi is delivered as a one-time infusion with a single dose containing 90 to 110 x 106 CAR-positive viable T cells.

The approval is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adults with relapsed or refractory MCL.

In patients treated with Breyanzi and evaluated for efficacy (n=68), 85.3% responded to treatment, with 67.6% achieving a complete response (CR).

Responses were rapid and durable, with a median time to response of one month and a median duration of response of 13.3 months with a median follow-up of 22.2 months.

More than half of responders remained in response at 12 months, and 38.8% of responders remained in response at 18 months.

Results from the primary analysis published in the Journal of Clinical Oncology (JCO) showed an overall response rate of 83.1% and a CR rate of 72.3%.

The median duration of response was 15.7 months, and progression-free survival was 15.3 months.

Price Action: BMY shares are up 1.9% at $41.05 at last check Friday.

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