FDA Approves Bristol Myers Squibb’s Breyanzi for Relapsed/Refractory Mantle Cell Lymphoma

Breyanzi (lisocabtagene maraleucel; liso-cel), developed by Bristol Myers Squibb, has received approval from the U.S. Food and Drug Administration (FDA) for treating adults with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two prior lines of systemic therapy, which must include a Bruton tyrosine kinase (BTK) inhibitor. This approval establishes Breyanzi as the sole CAR T cell therapy sanctioned by the FDA for four different subtypes of non-Hodgkin lymphoma (NHL), thereby offering a broader range of treatment options for patients with B-cell malignancies.

Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, is delivered through a one-time infusion consisting of 90 to 110 million CAR-positive viable T cells. The FDA's decision is anchored on data from the MCL cohort of the TRANSCEND NHL 001 trial, which included adults with relapsed or refractory MCL who had previously received at least two treatments, including a BTK inhibitor. The study revealed that Breyanzi produced responses in 85.3% of the patients, with 67.6% achieving a complete response. Responses were swift, typically occurring within a month, and were durable, with a median duration of response of 13.3 months.

MCL is a rare but aggressive form of NHL. Despite initial treatments, many patients experience relapse or resistance, making the disease difficult to manage. Breyanzi offers a new treatment avenue, providing high rates of lasting responses and maintaining a consistent safety profile, which is critical for patients with limited options.

The clinical efficacy of Breyanzi was demonstrated in its ability to elicit a high overall response rate (85.3%) and a complete response rate of 67.6%. The treatment process included leukapheresis, manufacturing, administration, and adverse event monitoring. The therapy's safety profile was consistent across trials, with cytokine release syndrome (CRS) and neurologic toxicities being the primary concerns. CRS occurred in 54% of patients, and neurologic events were observed in 31% of patients, with the majority resolving within days.

Breyanzi’s approval is a significant step forward, offering a new treatment option for patients with relapsed or refractory MCL. This approval is part of a broader clinical development program by Bristol Myers Squibb, which is committed to increasing the accessibility of this therapy through substantial investments in manufacturing capacity. The company also provides various support programs and resources to aid patients and caregivers in accessing Breyanzi.

The full spectrum of Breyanzi's indications includes treatment for large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and now mantle cell lymphoma (MCL). This breadth of applications positions Breyanzi as a vital component in the therapeutic landscape for various aggressive B-cell malignancies.

Given the aggressive nature of MCL and the limited treatment options available, the approval of Breyanzi represents a crucial advancement in the management of this challenging disease. The therapy's ability to provide durable responses with a manageable safety profile offers hope to patients who have exhausted other treatment avenues.

In summary, the FDA's approval of Breyanzi for MCL underscores the significant progress in CAR T cell therapy, potentially transforming the treatment paradigm for patients with relapsed or refractory mantle cell lymphoma. As Bristol Myers Squibb continues to expand its clinical trials and manufacturing capabilities, the accessibility and impact of Breyanzi are poised to grow, offering new hope to patients battling these formidable forms of cancer.