Bayer’s Stivarga has received a final green light from the National Institute for Health and Care Excellence (NICE) for use by the NHS to treat advanced liver cancer.
Stivarga (regorafenib) is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had Nexavar (sorafenib), but only if they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
This means they are fully active and able to carry on all pre-disease performance without restriction or they are restricted in physically strenuous activity but able to carry out work of a light or sedentary nature.
According to NICE, a few hundred patients each year will benefit from the decision, which marks a turnaround from a guidance published earlier in the year which rejected the drug.
However, “after including analyses with a new commercial arrangement which makes regorafenib available to the NHS with a confidential discount, NICE now considers the drug to have met its criteria as a being a cost effective and life-extending end of life treatment,” it said.
Stivarga is oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumour angiogenesis.
In one clinical trial underpinning its approval in patients with unresectable HCC whose disease had progressed during treatment with Nexavar (sorafenib), the drug significantly improved overall survival (OS) compared to placebo, with a 2.8-month difference in median OS (10.6 months versus 7.8 months), respectively. Also, Stivarga was linked with an overall 37 percent reduction in the risk of death.
“Regorafenib for HCC offers the first licensed treatment option following failure on sorafenib which could significantly improve patients overall survival," said Manjinder Bains, medical director Oncology, Bayer UK, recently said.
According to the British Liver Trust, in the UK there are more than 5,500 new cases of primary liver cancer diagnosed each year, which is around 15 patients each day.