pharmafileNovember 30, 2018
The National Institute for Health and Care Excellence (NICE) has voiced its recommendation for Bayer’s Stivarga (regorafenib) for use on the NHS in England and Wales in the treatment of advanced unresectable hepatocellular carcinoma (HCC), the manufacturer has revealed.
Specifically, the therapy is recommended for adult patients who have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and have already received Nexavar (sorafenib).
The licensing was based on international Phase 3 data which showed that a combination of Stivarga and best supportive care (BSC) improved overall survival by 10.6 months compared to 7.8 months with placebo and BSC – a 37% relative risk reduction in risk of death.
"There is a great unmet need for liver cancer patients and their treating physicians as, until now, treatment options have been severely limited," commented Professor Daniel Palmer of the University of Liverpool. "The positive recommendation by NICE for regorafenib in HCC means patients can now have access to a proven treatment plan involving the use of regorafenib directly after sorafenib, a plan which could significantly improve the outlook for this patient population."
Manjinder Bains, Medical Director of Oncology at Bayer UK, also remarked: "Regorafenib for HCC offers the first licensed treatment option following failure on sorafenib which could significantly improve patients overall survival. As a company, we welcome the positive decision by NICE and are dedicated to ensuring access to the latest treatment advances to patients living in the UK."
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