The European Commission (EC) has granted expanded approval to Bristol Myers Squibb’s (BMS) cluster of differentiation 19 (CD19)-directed chimeric antigen receptor (CAR) T cell therapy, Breyanzi (lisocabtagene maraleucel; liso-cel), to treat adults with relapsed or refractory follicular lymphoma (FL).
The approval is intended to be followed by two or more lines of systemic therapy.
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EC’s expanded approval is supported by the outcomes from the multicentre, open-label Phase II TRANSCEND FL trial – the largest to assess a CAR T cell therapy in subjects with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), inclusive of FL.
BMS Europe Region senior vice-president Emma Charles stated: “This additional approval for Breyanzi in FL represents a critical step forward in our mission to deliver on the transformational promise of cell therapy for more patients across Europe.
“While significant advancements have been made in the last two decades, there still remains unmet need for patients. Newer treatments for FL, like Breyanzi , have shown impactful results in clinical trials, with the opportunity to deliver lasting results in the routine care setting.”
In the third-line setting and beyond, the cell therapy showed a 97.1% overall response rate – the primary endpoint of the trial, and a 94.2% complete response – the secondary endpoint.
This approval extends to all member states of the European Union (EU), along with Norway, Liechtenstein and Iceland.
The centralised marketing authorisation does not include the UK.
The cell therapy has also received approval for several other lymphomas in the EU and other regions, including the UK, Switzerland, Canada and Japan.
It is made by genetically re-engineering an individual’s T cells into CAR T cells, which are then infused back into the individual as a single-time treatment.
BMS recently agreed to acquire 2seventy bio, a cell therapy partner, for $286m.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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