Saturday, June 22, 2024

FDA Approves New CAR T Therapy for Mantle Cell Lymphoma

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The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Breyanzi as a new CAR T cell therapy for relapsed or refractory mantle cell lymphoma (MCL). This approval offers a new digital therapeutic device for patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, is now the only CAR T cell therapy approved by the FDA for four distinct subtypes of non-Hodgkin lymphoma, making it available to a broad range of patients with B-cell malignancies. In clinical trials, Breyanzi delivered responses in 85.3% of patients with a one-time infusion, demonstrating a consistent safety profile across studies.

Significant Impact on Mantle Cell Lymphoma Treatment

MCL is a rare but aggressive form of non-Hodgkin lymphoma, and many patients relapse or become resistant to frontline therapies. The approval of Breyanzi provides a crucial new treatment option with high rates of lasting responses and a consistent safety profile. This is particularly important for patients who currently have limited options to treat this aggressive disease.

The FDA approval is based on results from the MCL cohort of TRANSCEND NHL 001. In this study, 85.3% of patients responded to treatment with Breyanzi, with 67.6% achieving a complete response. Responses were rapid and durable, with a median time to response of one month and a median duration of response of 13.3 months. More than half of the responders remained in response at 12 months, and nearly 39% remained in response at 18 months.

Breyanzi has shown a consistent safety profile across clinical trials involving 702 patients. Any grade cytokine release syndrome (CRS) occurred in 54% of patients, including Grade 3 or higher in 3.2% of patients. Neurologic events were reported in 31% of patients, with severe cases in 10%. The safety profile allows for the option of outpatient treatment and management of patients, enhancing accessibility and convenience.

mantle cell lymphoma

Support for Patients and Providers

Bristol Myers Squibb has invested in increasing manufacturing capacity to meet demand for Breyanzi. The company offers various programs and resources to support patients and caregivers, ensuring access to therapies. The Cell Therapy 360 platform provides digital services to optimize access to relevant information, manufacturing updates, and patient and caregiver support.

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, enhancing the expansion and persistence of CAR T cells. It is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells. These are then delivered via infusion as a one-time treatment, offering a new approach to tackling relapsed or refractory MCL.

The approval of Breyanzi brings a new, potentially transformative treatment option to patients battling relapsed or refractory MCL. This marks an important progress in improving outcomes for patients with limited treatment options. The continuous investments by Bristol Myers Squibb in this area reflect the company’s commitment to advancing cancer treatment and providing better care for patients.

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Breyanzi is also approved for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, and has received accelerated approval for chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma. It is approved in the U.S., Japan, the European Union, Switzerland, the UK, and Canada for various indications.

 

Resource: Bristol Myers Squibb, May 30, 2024

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