The European Commission (EC) has approved Bristol Myers Squibb Co's (NYSE:BMY) Breyanzi (lisocabtagene maraleucel; liso-cel) in relapsed or refractory lymphoma settings.
- The approval for CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy covers 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.
- Breyanzi is delivered as a personalized treatment via a single infusion.
- Related: Bristol Myers Squibb Scores Three Back To Back European Approvals For Opdivo In Esophageal, Urothelial Cancer.
- The European approval is based on results from the TRANSCEND NHL 001 study in which 73% of patients achieved a response, including 53% who had minimal or no detectable lymphoma remaining following treatment.
- The median duration of response was 20.2 months in all responders, and for patients who achieved a CR, the median duration of response was 26.1 months.
- Price Action: BMY shares are up 1.12% at $74.61 during the market session on the last check Tuesday.
