Roche announced Friday that the FDA approved its filing for the PD-L1 inhibitor Tecentriq (atezolizumab) plus Avastin (bevacizumab) to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The company noted that the combination is the first cancer immunotherapy regimen cleared for use in this indication.
The decision "brings a cancer immunotherapy option to people with this aggressive form of liver cancer," commented Levi Garraway, Roche's head of global product development, who noted that the filing 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 US and around the world." Along with the FDA filing, simultaneous applications were also submitted to regulators in Australia, Canada and Singapore under Project Orbis.
The approval was based on results from the Phase III IMbrave150 study of patients with unresectable HCC who had not undergone prior systemic therapy, and who were randomised to receive Tecentriq plus Avastin, or standard-of-care with Bayer's Nexavar (sorafenib) alone. Results, which were recently published in the NEJM, demonstrated that adding Tecentriq to Avastin cut the risk of death by 42% and the risk of disease worsening or death by 41%, compared with Nexavar.
Tecentriq is approved in multiple markets, including the US and Europe, either alone or in combination with targeted therapies and chemotherapies for various forms of non-small-cell and small-cell lung cancer, certain types of metastatic urothelial cancer and in patients with PD-L1-positive metastatic triple-negative breast cancer. Roche recently reported that sales of Tecentriq nearly doubled in the first quarter versus the year-ago period to CHF 644 million ($670 million).
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