Therapy Areas: Central Nervous System
US FDA Approves Bristol Myers Squibb's CAR T Cell Therapy Breyanzi for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
24 June 2022 - - The US Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor T cell therapy, for the treatment of adult patients with large B-cell lymphoma, US-based biopharmaceutical company Bristol Myers Squibb (NYSE: BMY) said.

This approval covers diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.

With these two new indications, Breyanzi now has the broadest patient eligibility of any CAR T cell therapy in relapsed or refractory LBCL. 

Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

Breyanzi has demonstrated clinically meaningful and statistically significant improvements in event-free survival, complete responses and progression-free survival compared to standard therapy in patients with LBCL that is primary refractory or relapsed within 12 months after first-line therapy.

An improvement in EFS represents an increase in the length of time in which patients are alive and without disease progression or in need of further treatment. 

Breyanzi, a differentiated CAR T cell therapy, is made from a patient's own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. 

Breyanzi can be administered in the inpatient or outpatient setting at a certified treatment center.

Breyanzi is the only CAR T cell therapy that has been evaluated in a broad second-line patient population for LBCL in two distinct company-sponsored studies, including in patients whose disease relapsed within or later than 12 months following first-line treatment and regardless of transplant candidacy.

The approval of the expanded indications for Breyanzi is based on results from the pivotal Phase 3 TRANSFORM study in which adults with LBCL that was primary refractory or relapsed within 12 months of front-line therapy were randomized to receive Breyanzi or standard therapy consisting of salvage immunochemotherapy, and if responsive, high-dose chemotherapy and HSCT.

The trial included patients with diverse histologic subtypes and high-risk features, and offered a patient-centric design, allowing for bridging immunochemotherapy in the Breyanzi arm for disease control, which reflects real-world clinical practice and allowed for inclusion of patients with more aggressive and fast-progressing disease.

Due to the high rate of patients whose disease does not respond to salvage immunochemotherapy, the trial also allowed for crossover from the standard therapy arm to the Breyanzi arm if patients did not derive a response after three cycles of salvage chemotherapy or had disease progression at any time.

Results from the TRANSFORM study showed, Breyanzi (n=92) more than quadrupled median EFS compared to standard therapy (10.1 months vs. 2.3 months [HR: 0.34; 95% CI (0.22-0.52) p
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