Bayer’s lung cancer treatment gains final NICE Recommendation


Bayer’s Regorafenib has received a final approval from NICE for use by the NHS to treat advanced liver cancer.

Regorafenib is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had Sorafenib, however they can only receive the treatment if they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Meaning patients 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.

Nice stated that a few hundred patients each year will benefit from the decision, marking a turnaround from a guidance published earlier in the year which rejected the drug.

However it stated the following, “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 being a cost effective and life-extending end of life treatment,”.

Regorafenib 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 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. Regorafenib was also linked with an overall 37% 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.

Data from the British Liver Trust states there are more than 5,500 new cases of primary liver cancer diagnosed each year in the UK, which is approximately 15 patients each day.

Source: Pharmatimes