Regulatory Decision Summary for Breyanzi

Marketing authorization was based on the results of two multi-centre, open-label, single arm trials. Patients in each trial (main trial, n = 176, and supportive trial, n = 37) were adult patients with a median age of 63 with one of the following B-cell histologies: Diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS); DLBCL transformed from follicular lymphoma (tFL); high-grade B-cell lymphoma (HGL); and primary mediastinal large B-cell lymphoma (PMBCL). Patients were infused with a single dose of Breyanzi. The primary endpoint of overall response rate (ORR) was met in each trial. The key secondary endpoint, complete remission, was also met, and the duration of the response appears to be longer than current non-CAR T cell based therapies. 

The most common adverse drug reactions (ADRs) associated with Breyanzi occurring in at least 30% of patients in both studies were: low neutrophil counts; anaemia; fatigue; cytokine release syndrome (CRS); nausea; low platelet count; and headache. Adverse neurological events (ANEs) also occurred in some patients. Specific details for monitoring and managing CRS and ANEs after Breyanzi infusion are provided in the Product Monograph (PM). Due to the seriousness of ADRs associated with Breyanzi, infusion of the Drug Product is restricted to institutions that are staffed by health care providers that are well trained and experienced in managing patients undergoing this therapy and who have participated in education programs that focus on monitoring and treatment of such ADRs. 

For the patients with relapsed or refractory cancers that are described above, there are no standardized treatment options after two lines of therapy. Although there are serious side effects that can occur with Breyanzi, the benefit/risk ratio is considered favourable when Breyanzi is administered under supervision of trained health care providers in a treatment facility as described in the PM. 

Breyanzi is comprised of two components. The recommended dose of Breyanzi is 60 million – 120 million CAR positive T cells with the ratio between the two components being 1:1. 

An updated Risk Management Plan (RMP) for Breyanzi was reviewed by Health Canada and considered acceptable.

For further details about Breyanzi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.