Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) 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 (HCC), the most common form of liver cancer. The designation is based on data from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin.
"Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide," said Sandra Horning, MD, 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."
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. This is the 22nd Breakthrough Therapy Designation for Roche’s portfolio of medicines and the 3rd for Tecentriq.
Read more: http://www.worldpharmanews.com/roche/4491-fda-grants-breakthrough-therapy-designation-for-roche-s-tecentriq-in-combination-with-avastin-as-first-line-treatment-for-advanced-or-metastatic-hepatocellular-carcinoma-hcc