EMA validates application for CAR-T cell therapy Breyanzi from BMS

21 June 2022

The European Medicines Agency (EMA) has validated the type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat 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).

Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure, noted the drug’s developer, US pharma major Bristol Myers Squibb (NYSE: BMY).

Just a couple of months ago, Breyanzi gained European Commission approval for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.

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