The US Food and Drug Administration (FDA) has granted Roche (SWX: ROG) Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer, the multinational pharmaceutical company disclosed on Wednesday.
This designation was based on data from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin. Data from the study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting which took place in June.
The data revealed that, after a median follow-up of 10.3 months, responses were seen in 15 (65%) of 23 efficacy-evaluable patients. Median progression-free survival, duration of response, time to progression, and overall survival were not reached after a median follow-up of 10.3 months. No new safety signals were identified beyond the established safety profiles for the individual medicines.
Breakthrough Therapy Designation is designed to speed up the development and review of medicines to treat serious or life-threatening diseases. It also helps provide patients with access to the medicines via FDA approval as soon as possible.
This latest Breakthrough Therapy Designation is the 22nd for Roche's portfolio of medicines and the third for Tecentriq.
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