Bristol Myers Squibb has garnered FDA approval for Breyanzi, a CAR-T cell therapy for relapsed or refractory mantle cell lymphoma (MCL). This marks the fourth subtype of non-Hodgkin lymphoma treatable with Breyanzi, making it the most widely applicable CAR T cell therapy for B-cell malignancies.
Breyanzi requires only one infusion of CAR-positive viable T cells for MCL treatment. In clinical trials, it demonstrated high response rates with a consistent safety profile.
MCL is an aggressive lymphoma with limited treatment options. With each relapse, the prognosis worsens, making deep and durable responses challenging. Breyanzi offers a significant advancement for these patients, providing a potentially curative option.
Dr. Michael Wang of the University of Texas MD Anderson Cancer Center emphasizes the importance of this approval, given the limited treatment options for relapsed or refractory MCL. He highlights the high response rates and consistent safety profile of Breyanzi, which are crucial for patients facing the challenges of this aggressive disease.
The approval is based on the MCL cohort of the TRANSCEND NHL 001 trial, which demonstrated a response rate of 85.3% with a one-time infusion. Breyanzi’s expanded indications include diffuse large B-cell lymphoma, follicular lymphoma, and high-grade B-cell lymphoma.
Bristol Myers Squibb’s commitment to cell therapy innovation continues with Breyanzi, offering personalized and potentially definitive treatment for various B-cell malignancies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.