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Regorafenib approved for advanced hepatocellular carcinoma

NICE has approved regorafenib (Stivarga) as an option for treating advanced unresectable hepatocellular carcinoma (HCC) in adults who have had sorafenib, have Child-Pugh grade A liver impairment and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

After an initial decision not to recommend the treatment back in March, NICE says a confidential discount agreed with the pharmaceutical company has allowed the drug to meet the criteria for being a cost-effective and life-extending end-of-life treatment.

The decision is based on clinical evidence from the RESORCE (n=573) trial - an international, phase 3, randomised, double-blind, placebo-controlled trial comparing regorafenib (plus best supportive care) with placebo (plus best supportive care).

RESORCE showed a small but statistically significant median overall survival (OS) gain of 2.8 months for regorafenib (10.6 months; 95% CI 9.1-12.1) vs best supportive care (7.8 months; 95% CI 6.3-8.8). The hazard ratio for OS for regorafenib compared with best supportive care was 0.63 (95% CI 0.50-0.79).

Median progression-free survival (PFS) was statistically significantly better for regorafenib (3.1 months; 95% CI 2.8-4.2) vs best supportive care (1.5 months; 95% CI 1.4-1.6), equating to a hazard ratio of 0.46 (95% CI 0.37-0.56).

Commenting on the decision, Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said: “We are pleased that the company has responded by seeking a rapid review of our original guidance and offered a price that allows us to conclude that the drug is cost-effective for routine use on the NHS in England and Wales.”


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