FDA grants accelerated approval for BMS’ Breyanzi in FL

The US Food and Drug Administration yesterday granted accelerated approval to Breyanzi (lisocabtagene maraleucel; liso-cel), from US pharma major Bristol Myers Squibb (NYSE: BMY), for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). BMS noted that Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.

Efficacy was evaluated in TRANSCEND-FL (NCT04245839), a Phase II, open-label, multicenter, single-arm trial in adults with relapsed or refractory FL after two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent). Patients were eligible to enroll in the study if they had adequate bone marrow function to receive lymphodepleting chemotherapy and an ECOG performance status of 1 or less.