Swiss multi-national healthcare company, Roche (SIX: RO, ROG; OTCQX: RHHBY), announced on Tuesday that the US Food and Drug Administration (FDA) has approved Tecentriq(R) (atezolizumab) in combination with Avastin(R) (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
'We're excited that today's approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,' said Levi Garraway, MD, PhD, CMO and head of Global Product Development. 'The application was reviewed under the FDA's Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.'
The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p
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