FDA Accepts Roche’s Supplemental Biologics License Application for Gazyva/Gazyvaro in Lupus Nephritis
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...
For patients with active lupus nephritis, obinutuzumab, a humanized type II anti-CD20 monoclonal antibody plus standard ...
The triple-drug combination of fixed-duration ibrutinib–venetoclax–obinutuzumab in the phase 3 GAIA-CLL13 trial involving fit patients (i.e., those with a low burden of coexisting conditions ...
Adding the anti-CD20 monoclonal antibody obinutuzumab (Gazyva) to standard therapy for lupus nephritis is more efficacious than standard therapy alone, according to a new phase 3, placebo ...
The superior effects of obinutuzumab seen in the laboratory have been confirmed in clinical trials and, in 2013, the drug was the first drug to be awarded Breakthrough Therapy Designation by the ...
Adding obinutuzumab to standard therapy for active lupus nephritis led to significantly higher rates of complete renal ...
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