FDA approves Bristol Myers Squibb’s Breyanzi

VaselineMay 17, 2024

0 4 minutes read

FDA approves Bristol Myers Squibb’s Breyanzi

Breyanzi is indicated for use in patients with FL who have received at least two prior systemic therapies. Credit: Bristol Myers Squibb/Business Wire.

The US Food and Drug Administration (FDA) has granted accelerated approval for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) for adult patients with relapsed or refractory follicular lymphoma (FL).

CD19-directed chimeric antigen receptor (CAR) T-cell therapy is indicated for patients who have undergone at least two prior systemic therapies.

Given as a single infusion, Breyanzi delivers a dose of 90 to 110 × 10⁶ viable CAR-positive T cells to patients.

The approval is based on the results of the open-label, global, multicenter, single-arm phase II TRANSCEND FL clinical trial evaluating the efficacy and safety of Breyanzi.

The primary outcome measure was overall response rate, while secondary measures included complete response rate, duration of response, progression-free survival, and safety.

The study demonstrated an overall response rate of 95.7%, while the complete response rate was 73.4%.

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Responses were reported to be rapid, with an average time of one month, and durable. The average response time has not yet been reached.

At 12 and 18 months, the majority remained in response.

Breyanzi has demonstrated a consistent safety profile throughout the studies.

Cytokine release syndrome (CRS) of any grade was reported in 53% of subjects with grade >3 CRS observed in 4% of patients.

Bristol Myers Squibb Cell Therapy Commercial Head and Senior Vice President Bryan Campbell said: “Breyanzi is a cornerstone of our cell therapy portfolio, offering a differentiated profile across a broad range of B-cell malignancies.

“Breyanzi’s approval for relapsed or refractory FL offers an option with the potential for durable remission in a single infusion and a safety profile that allows both in-hospital and outpatient administration and monitoring in an increasingly large number of certified treatment centers in the US.”

Last month, the European Commission granted expanded approval for Bristol Myers Squibb’s Reblozyl (luspatercept) as first-line treatment for adults with transfusion-dependent anemia associated with very-low, low- and intermediate-risk myelodysplastic syndromes.

VaselineMay 17, 2024

0 4 minutes read

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