FDA grants breakthrough therapy designation to Tecentriq in combination with Avastin

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC).

This designation has been based on data from a Phase Ib study, which assessed the safety and clinical activity of the combination of Tecentriq and Avastin, and should speed up the development and review of the combination therapy.

“Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide,” said Dr Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “Preliminary data from the combination of Tecentriq and Avastin in this disease are promising and we look forward to working with health authorities to make this potential treatment regimen available to people with hepatocellular carcinoma as soon as possible.”

The Phase Ib study data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, in June 2018, and demonstrated that after just over 10 months follow up about two thirds of those involved responded to treatment.