Shots:

• The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg- q3w- IV) vs sorafenib (400mg- bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC- prior not treated with systemic therapies
• Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease worsening or death (PFS); @primary analysis- median survival follow up time (8.6mos.); 7.6mos. delay in median time to deterioration of patient-reported QoL
• The approval is part of Project Orbis- an initiative of the FDA’s OCE which provides a framework for simultaneous submission and review of oncology products among international partners

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Ref: Roche | Image: Roche