Bristol Myers Squibb’s Breyanzi has received accelerated FDA approval for adult patients with relapsed or refractory follicular lymphoma who have undergone at least two prior therapies.

Breyanzi is a personalized therapy that uses chimeric antigen receptor (CAR) T cells to target CD19, a protein found in lymphoma cells. The treatment involves a single infusion of CAR-positive T cells directly into the patient’s bloodstream.

In the Phase 2 TRANSCEND FL clinical trial, 95.7% of patients responded to Breyanzi, with a median duration of response that was not yet reached. At 18 months, 77.1% of responders maintained an ongoing response.

Breyanzi offers several advantages over other treatments. It provides durable responses with a consistent safety profile across clinical trials. Additionally, its one-time infusion allows for administration and monitoring in inpatient and outpatient settings.

Historically, follicular lymphoma has been considered incurable, and patients often relapse after initial treatment. Breyanzi addresses the need for more effective and long-lasting therapies for this condition. Targeting CD19 offers a potential for complete remission and extended treatment-free intervals.

Source link: http://www.businesswire.com/news/home/20240515772899/en/Bristol-Myers-Squibb%E2%80%99s-CAR-T-Cell-Therapy-Breyanzi-Approved-by-the-U.S.-Food-and-Drug-Administration-for-Relapsed-or-Refractory-Follicular-Lymphoma

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.