EMA convalida la domanda di estensione d'indicazione di Breyanzi (lisocabtagene maraleucel) in 3L nel linforma follicolare.

EMA has validated its extension of indication for Breyanzi (lisocabtagene maraleucel) to include treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

The application is supported by data from the Phase 2 TRANSCEND FL study, an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma. The primary outcome measure is overall response rate, including best overall response of complete response or partial response as determined by an Independent Review Committee. Secondary outcome measures include complete response rate, duration of response, progression-free survival, and safety.

Reference link: BMS press release