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FDA Grants Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma as New CAR T Cell Therapy

NextEdge Admin

31 May 2024

3 min 37 sec

$Refractory,CAR T Cell Therapy$

Bristol Myers Squibb (BMS) has received FDA approval for Breyanzi® (lisocabtagene maraleucel; liso-cel) as a treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. This marks Breyanzi’s fourth FDA approval, positioning it as the CAR T cell therapy with the broadest spectrum for B-cell malignancies.

MCL is a rare and aggressive form of non-Hodgkin lymphoma with limited treatment options, especially for those who relapse or become resistant to initial therapies. Breyanzi offers a promising solution by providing high response rates and durable responses, addressing a critical unmet need in this patient population.

Clinical trials demonstrated that Breyanzi elicited an overall response rate of 85.3%, with 67.6% achieving a complete response. Responses were rapid and durable, with a median duration of response of 13.3 months. Importantly, more than half of responders remained in response at 12 months, indicating sustained efficacy.

Safety data showed a consistent profile across trials, with manageable incidences of cytokine release syndrome (CRS) and neurologic events (NEs). Notably, CRS occurred in 54% of patients, with only 3.2% experiencing Grade >3 CRS. NEs were reported in 31% of patients, with Grade >3 NEs in 10%, but most resolved with a median duration of 7 days.

BMS is prepared to meet the demand for Breyanzi by investing in manufacturing capacity. Moreover, the therapy is broadly covered by insurance programs in the U.S., and BMS offers support programs to facilitate access for patients and caregivers. The Cell Therapy 360 digital service platform provides relevant information and support throughout the treatment journey.

TRANSCEND NHL 001, the pivotal Phase 1 study, demonstrated Breyanzi’s safety, pharmacokinetics, and antitumor activity in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including MCL. MCL, representing approximately 3% of all NHL cases, typically occurs in older adults and often relapses after initial treatment.

Breyanzi, a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, is made from a patient’s own T cells, genetically engineered to enhance expansion and persistence. It is administered as a one-time infusion, offering a transformative treatment option for patients with relapsed or refractory MCL.