FDA grants accelerated  approval of  Breyanzi for Follicular Lymphoma treatment

USA—The FDA recently granted accelerated approval for Bristol Myers Squibb’s Breyanzi to treat patients with relapsed or refractory follicular lymphoma (FL). 

This approval offers a promising option for patients undergoing at least two prior systemic therapies.

Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, significantly advances FL treatment. 

Administered as a one-time infusion, it delivers a precise dose of 90 to 110 × 10⁶ CAR-positive viable T cells, targeting malignant cells with enhanced precision and efficacy.

The FDA’s decision is based on compelling data obtained from the Phase II TRANSCEND FL clinical trial, which was conducted globally across multiple centers. 

This open-label, single-arm study evaluated Breyanzi’s efficacy and safety, with impressive results shaping the approval process.

Key outcomes from the trial included an overall response rate of 95.7%, with a notable complete response rate of 73.4%.

 Response to treatment was rapid, typically observed within one month, and durable, with the median duration of response not yet reached. 

Even at 12 and 18 months post-treatment, most patients remained in response.

Safety remains paramount, and Breyanzi has demonstrated a consistent safety profile throughout clinical trials. 

Cytokine release syndrome (CRS), a common concern with CAR T cell therapies, was manageable. Any grade was reported in 53% of subjects, and Grade >3 CRS was observed in 4% of patients.

Bryan Campbell, Bristol Myers Squibb’s cell therapy commercial head and senior vice-president, emphasized Breyanzi’s pivotal role in their portfolio, stating, “Breyanzi is a cornerstone of our cell therapy portfolio, providing a differentiated profile across a wide array of B-cell malignancies.”

 He further highlighted the therapy’s potential for lasting remission and its adaptable safety profile, which is suitable for both inpatient and outpatient settings.

This approval offers hope for FL patients facing a challenging treatment journey. 

Historically considered incurable, FL often leads to relapse following initial therapies, necessitating innovative solutions to improve outcomes and quality of life.

In addition to the FDA’s decision, recent European developments further enhance the progress in hematologic malignancy treatment. 

In April 2024, the European Commission expanded approval for Bristol Myers Squibb’s Reblozyl (luspatercept), offering a new first-line treatment option for adults with transfusion-dependent anemia associated with myelodysplastic syndromes.

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