SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY.PK) announced the FDA has approved Gazyva/Gazyvaro for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies.
Separately, Roche announced positive results from the phase III IMvigor011 study evaluating Tecentriq or atezolizumab as an adjuvant treatment for people with muscle-invasive bladder cancer who are at risk of recurrence after surgery and have detectable circulating tumour DNA. In the ctDNA-guided setting, Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36%, both compared with placebo. The safety profile was consistent with previous studies of Tecentriq.
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