FDA接受罗氏在普通狼疮治疗中对Gazyva/Gazyvaro的申请

2026-04-21 13:22

Roche (RHHBY) Tuesday said that the US Food and Drug Administration has accepted its supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of systemic lupus erythematosus, with a decision expected by December.
If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this condition.
Filing based on the phase III ALLEGORY study showing 76.7% of patients achieved improvement versus 53.5% with placebo. The FDA is expected to make a decision on an approval by December 2026.
Gazyva/Gazyvaro is already approved in 100 countries for various types of haematological cancers. In the United States, Gazyva/Gazyvaro is part of a collaboration between Genentech and Biogen (BIIB).

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