US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European Commission (EC) for its Breyanzi (lisocabtagene maraleucel; liso-cel). The approval allows the drug to be used in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Clinical Trial Results
The EC’s approval is based on positive results from the global Phase II TRANSCEND FL study. In the trial, Breyanzi demonstrated a high overall response rate of 97.1% (95% CI: 91.7–99.4) and a complete response (CR) rate of 94.2% (95% CI: 87.8–97.8) among patients treated in the third-line plus setting. The primary and key secondary endpoints were met, showing rapid, durable, and sustained efficacy.
Safety Profile
Breyanzi’s safety profile was stable, with no new safety signals observed. Only 0.8% of patients experienced Grade 3 cytokine release syndrome (CRS), indicating a favorable risk-benefit profile.-Fineline Info & Tech
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