Posted by Michael Wonder on 31 May 2020
FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program.
Genentech, today announced that the U.S. FDA has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
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) 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<0.0001), compared with sorafenib.
