Breyanzi (Lisocabtagene maraleucel) - 2L DLBCL - EU Type II variation - EMA evaluation - positive CHMP opinion expected Feb 2023

A positive CHMP opinion is expected for Breyanzi (Lisocabtagene maraleucel) the extension of indication in 2L DLBCL on 23 February 2023.

The indication being proposed is: 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 are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant (HSCT).

The type II variation is supported by data from the pivotal Phase 3 TRANSFORM study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus HSCT

Assuming positive opinion adopted on 23 Feb 2023, EC decision will be received at the latest 01 May 2023.