Genentech announced positive top line results from the Roche-sponsored Phase III Pemphix study evaluating the efficacy and safety of Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). The study met the primary endpoint, and demonstrated that Rituxan is superior to MMF in achieving sustained complete remission. “The Pemphix study provides…
FDA Approves Genentech’s Rituxan For Pemphigus Vulgaris
The U.S. Food and Drug Administration (FDA) has approved Genentech’s Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 Genentech is a member of the Roche Group. Rituxan is the first biologic therapy approved by the FDA for…
FDA Approves Subcutaneous Formulation Of Actemra
The FDA has approved Genentech’s subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with PJIA. In 2013, FDA approved the intravenous (IV) formulation of Actemra for patients…
FDA Grants Priority Review Of Genentech’s Tecentriq
Genentech, a member of the Roche Group today announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC). The FDA is expected to…
Ocrelizumab Demonstrates Significant Reductions in Disease Activity and Disability Progression in Relapsing Multiple Sclerosis
Genentech’s Tecentriq And Avastin Helped People With Lung Cancer Live Longer
Genentech’s Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel.…
Genentech Kidney Cancer Treatment Reduces Worsening Of Disease In Some Patients
Phase III IMmotion151 study showed Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death by 26 percent in certain people with advanced kidney cancer. Genentech, a member of the Roche Group announced results from the positive Phase III IMmotion151 study of Tecentriq (atezolizumab) and Avastin (bevacizumab) as a first-line treatment for advanced or…
Genentech’s Tecentriq and Avastin Plus Chemo Reduced Disease Worsening Risk or Death by 38 Percent for People with a Type of Advanced Lung Cancer
Positive Results For Tecentriq-Avastin-Chemo Combo In Lung Cancer
Phase III IMpower150 study showed Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer. Genentech, a member of the Roche Group, on Sunday announced that the Phase III IMpower150 study met its co-primary endpoint of…