Posted by Michael Wonder on 28 Jan 2020
Genentech submits supplemental biologics license application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer
26 January 2020 - Application is being reviewed under FDA's Real-Time Oncology Review pilot program.
Genentech today announced the completion of a supplemental biologics license application submission to the U.S. FDA for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted breakthrough therapy designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.
