CHMP adopts a positive opinion for change to the terms of the marketing authorisation for Breyanzi (isocabtagene maraleucel) – BMS

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Breyanzi. The marketing authorisation holder is BMS Pharma EEIG.

The CHMP adopted a new indication: Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.