SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche (RHHBY) announced Tuesday that the US Food and Drug Administration has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat the most common, aggressive form of liver cancer.
The approval is for treatment of people with unresectable or metastatic hepatocellular carcinoma or HCC, who have not received prior systemic therapy.
According to the company, Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic HCC.
The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death by 42% and reduced the risk of disease worsening or death by 41%, compared with sorafenib.
Levi Garraway, Chief Medical Officer and Head of Global Product Development, said, 'The application was reviewed under the FDA's Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.'
Roche's extensive development programme for Tecentriq includes multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.
This includes studies evaluating Tecentriq both alone and in combination with other medicines.
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