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Roche’s Tecentriq/Avastin combo wins US approval

Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen cleared to treat unresectable or metastatic liver cancer

US regulators have approved a combination of Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) to treat unresectable or metastatic hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy.

Approval was based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin cut the risk of death by 42% and reduced the risk of disease worsening or death by 41% compared with sorafenib.

According to the Swiss drug giant, IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in overall and progression free survival in people with unresectable or metastatic HCC compared with sorafenib.

“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,” said Dr Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center.

“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.”

“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,” added Levi Garraway, chief medical officer and head of global product development at Roche.

Project Orbis provides a framework for concurrent submission and review of oncology medicines among international partners, in the hope of providing cancer patients with earlier access to products in other countries where there may be significant delays in regulatory submissions.

In this case, Roche essentially submitted simultaneous applications to regulators in the US, Australia, Canada and Singapore under the initiative.