publication date: Jul. 20, 2018
Drugs & Targets FDA grants breakthrough designation for Tecentriq + Avastin as first-line treatment for hepatocellular carcinoma
Genentech, a member of the Roche Group, said FDA has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial treatment for people with advanced or metastatic hepatocellular.
The designation is based on data from a phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin. Genentech presented data from a phase Ib study in HCC at the American Society of Clinical Oncology Annual Meeting in June.
These data showed that after a median follow-up of 10.3 months, responses (independent review facility per RECIST v1.1) were seen in 15 (65 percent) of 23 efficacy-evaluable participants. Responses were seen in all subgroups, including on the basis of the cause of their disease (etiology: Hepatitis B, Hepatitis C and non-viral), region (Asia [excluding Japan] or Japan/U.S.), baseline alpha-fetoprotein levels (high/low) or spread of tumor beyond the liver (yes/no). Assessment by investigators assessed per RECIST v1.1 demonstrated a response rate of 61 percent (14 out of 23 participants). Median progression-free survival, duration of response, time to progression, and overall survival have not yet been reached after a median follow-up of 10.3 months; results will be presented at a future medical congress when updated data from an … Continue reading FDA grants breakthrough designation for Tecentriq + Avastin as first-line treatment for hepatocellular carcinoma
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