Roche: submits application for Tecentriq for liver cancer
(CercleFinance.com) - Roche has announced that it has submitted an application to the FDA for an additional biological product license for Tecentriq, in combination with Avastin, to treat patients with unresectable hepatocellular carcinoma who have not received previous systemic therapy.
"The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible," the group said.
This application is based on the results of the Phase III 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".
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"The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible," the group said.
This application is based on the results of the Phase III 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".
Copyright (c) 2020 CercleFinance.com. All rights reserved.