EU - Breyanzi EC Decision and SmPC released in 2L LBCL extension of indication

MS has announced that the European Commission has issued its Decision for Breyanzi's (lisocabtagene maraleucel) extension of indication to include the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

The approval was based on data from the TRANSFORM (NCT03575351) study, a pivotal, global, randomized, multicenter Phase 3 trial evaluating Breyanzi compared to current standard of care (platinum-based salvage chemotherapy followed by high-dose chemotherapy and autologous hematopietic stem cell transplant [HSCT] in patients responding to salvage chemotherapy) in patients with large B-cell lymphoma that was primary refractory or relapsed within 12 months after CD20-antibody and anthracycline containing first-line therapy. 

The extension of indication was granted a positive Opinion by the CHMP in March 2023.

Reference link: BMS press release; Breyanzi updated SmPC (Union Register); Breyanzi EC Decision (Union Register)