Roche announced that the US FDA had approved Tecentriq in combination with Avastin, for the treatment of metastatic or unresectable hepatocellular carcinoma, in people who haven't received systemic therapy.
The approval was based on results, published in the New England Journal of Medicine, from the Phase 3 IMbrave150 study, revealing that Avastin and Tecentriq reduced the risk of death by forty-two per cent and reduced the risk of the worsening of disease or death by forty-one per cent compared with sorafenib. Furthermore, thirty-eight per cent of people in the Tecentriq and Avastin arm suffered from significant adverse reactions and the most frequent severe adverse reactions, below two per cent, were bleeding in the gastrointestinal tract, fever and infections.
“US FDA approved Roche's Tecentriq in combination with Avastin.“
Head of Global Product Development and Chief Medical Officer, M.D., Ph.D., Levi Garraway, stated: “We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer. 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.”
Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center and Professor of Medicine at the David Geffen School of Medicine at UCLA, Dr Richard Finn, stated: “The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first line setting. For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first line hepatocellular carcinoma since two-thousand and seven and offers patients the opportunity for improved disease control with a favourable tolerability profile.”