Genentech, a subsidiary of Roche, has secured the US Food and Drug Administration (FDA) approval for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat a type of liver cancer.
The US regulatory agency indicated Tecentriq plus Avastin for people with metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Tecentriq is a monoclonal antibody that binds with a protein called PD-L1, to inhibit its expression on tumour cells and tumour-infiltrating immune cells Avastin is a biologic antibody that binds to VEGF, a protein that plays a key role in the lifecycle of the tumour.
Roche global product development head and chief medical officer Levi Garraway said: “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.”
The FDA approval for Tecentriq plus Avastin was based on results from the Phase 3 IMbrave150 study
The company said that its application was reviewed by the FDA under the Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.
In addition, the FDA has rapidly reviewed and granted approval under its Real-Time Oncology Review (RTOR) pilot programme, which encourages the exploration of the effective review process.
The FDA approval was supported by the results from Phase 3 IMbrave150 study, which demonstrated that Tecentriq plus Avastin reduced 42% risk of death or overall survival (OS) and reduced 41% risk of disease worsening or progression-free survival (PFS) compared to sorafenib.
Genentech said that IMbrave150 marks the first Phase 3 cancer immunotherapy study to demonstrate an improvement in OS and PFS in people with unresectable or metastatic HCC, than sorafenib.
The most frequent serious adverse reactions in the study include bleeding in the gastrointestinal tract, infections and fever.
UCLA David Geffen School of Medicine professor Richard Finn said: “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 2007, and offers patients the opportunity for improved disease control with a favourable tolerability profile.”
