FDA Approves BMS CAR-T Cell Therapy

Bristol Myers Squibb received approval from the FDA for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

The approval is based on data from the TRANSCEND NHL trial in which 268 patients with R/R LBCL received Breyanzi. In the study, 192 patients were treated with Breyanzi at the dose of 50 to 110 x 106 CAR-positive viable T cells and evaluated for efficacy. Of these patients, 73% achieved a response, including 54% who had minimal or no detectable lymphoma remaining following treatment and 19% who achieved a partial response. Median duration of response was 16.7 months in all responders, and for patients who achieved a CR, median duration of response was not reached; for patients with a best response of PR, median duration of response was 1.4 months. Of 104 patients treated with Breyanzi who achieved a best overall response of CR, 65% had remission lasting at least six months and 62% had remission lasting at least nine months.

Bristol Myers Squibb plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facility in Bothell, WA. Breyanzi has a 24-day target turnaround time, and inpatient or outpatient administration options.

Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed. Seventy-three percent of patients will not respond to or will relapse following second-line treatment or later. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide sustained responses are limited and median life expectancy is about six months. The goal of treatment in DLBCL is curative intent with definitive therapy.

Breyanzi has been granted Priority Medicines (PRIME) designation for R/R DLBCL in the EU and a Marketing Authorization Application (MAA) is currently under review by the EMA.