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