Roche’s Gazyva shows breakthrough results in Lupus phase III trial
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations
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