EMA Validates Breyanzi for Follicular Lymphoma in High-Risk Patients

Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy. The European Medicines Agency (EMA) has validated Bristol Myers Squibb's Type II variation application to include adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Under the EMA's centralised review method, the applicant verifies that the submission is complete and permits the scientific review to start.

Breyanzi is a differentiated CAR T cell therapy, according to Bryson Myers Squibb's senior vice president and head of Late Clinical Development, Haematology, Oncology, and Cell Therapy (HOCT), Anne Kerber. The company looks forward to collaborating with the EMA to provide patients with relapsed or refractory follicular lymphoma with the goal of improving outcomes and providing lasting remission.

The biggest clinical trial to date to assess a CAR T cell treatment in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL, is the Phase 2 TRANSCEND FL study, whose results are used to support the application. Adults receiving Breyanzi treatment for FL who had relapsed or were resistant were recruited in the trial in the high-risk second-line and third-line plus settings.

Adult patients with 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 have relapsed within a year of finishing first-line chemotherapy or who are refractory to it can now receive Breyanzi approval in the European Union.