Genentech: FDA Grants Breakthrough Therapy Designation For TECENTRIQ For HCC

Genentech, a member of the Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma or HCC.

The designation is based on data from a Phase Ib study assessing the safety and clinical activity of the combination of TECENTRIQ and Avastin.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible.

Sandra Horning, chief medical officer and head of Global Product Development, said, "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."

Genentech presented data from a Phase Ib study in HCC at the American Society of Clinical Oncology Annual Meeting in June 2018.

Genentech provided additional data per FDA request and the Breakthrough Therapy Designation has been granted based on the totality of these data.

Earlier this year, Genentech initiated IMbrave150 (NCT03434379), an open-label, multicenter, randomized Phase III study investigating the combination of TECENTRIQ and Avastin versus sorafenib in people with previously-untreated (first-line) locally advanced, unresectable or metastatic HCC. This study is currently enrolling.

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