Positive CHMP Opinion for Breyanzi (liso-cel) for Relapsed or Refractory Follicular Lymphoma in 2L
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
The CHMP adopted a positive opinion based on data from the global, Phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL, which enrolled adults with relapsed or refractory FL treated with Breyanzi after two or more prior lines of systemic therapy.
In the study, Breyanzi demonstrated a high overall response rate of 97.1% (95% CI: 91.7–99.4) and complete response rate of 94.2% (95% CI: 87.8–97.8), the study’s primary and key secondary endpoints, respectively. Responses were rapid and durable, and demonstrated sustained efficacy with 75.7% (95% CI: 66.0–83.0) of patients in response at 18 months. The safety of Breyanzi in FL is consistent with the well-established safety profile of Breyanzi observed across clinical trials, with no new safety signals observed.
Breyanzi is currently approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and FL grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy.