NICE has issued draft guidelines backing use of Eisai/MSD’s Lenvima on the NHS in England and Wales as an option for a type of untreated, advanced liver cancer.

The Institute has issued a final appraisal document (FAD) recommending the use of Lenvima (lenvatinib) for untreated, advanced, unresectable hepatocellular carcinoma (HCC) in adults with Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Lenvima, an oral receptor tyrosine kinase (RTK) inhibitor, is the first new, approved first-line treatment for advanced or unresectable HCC in a decade to show an overall survival treatment effect that was non-inferior to the current standard of care (sorafenib), according to the firm.

The drug was approved for this use in August on the back of data showing that patients experienced a median overall survival of 13.6 months compared to 12.3 months with sorafenib, while median PFS was 7.3 months versus 3.6 months, respectively.

“Unfortunately, it is very common in the UK for people to be diagnosed with HCC at a very late stage, as people are often asymptomatic in the early stages of disease and it is challenging to detect. While liver cancer is the fastest growing cancer in the UK, outcomes for patients with advanced disease continues to be poor. Patients with HCC, the most common form of primary liver cancer, have a 5-year survival rate of only 12% and a diagnosis is truly devastating for patients”, said Judi Rhys, chief executive of the British Liver Trust.

“NICE’s approval of lenvatinib in the first-line setting is therefore a significant step for patients across England and Wales who have had very limited treatment options in the past.”

“The diagnosis of advanced HCC in a patient is challenging for the patient and their clinicians, since we are limited by the treatment choices available. This new option will allow us greater flexibility in managing patients who may not be suitable for other treatment options,” added Professor Daniel Palmer, North West Cancer Research Chair of Medical Oncology, Department of Molecular and Clinical Cancer Medicine, University of Liverpool.

Earlier this year, Eisai and MSD entered into a strategic collaboration for the worldwide co-development and co-commercialisation of Lenvima, both as monotherapy and in combination with anti-PD-1 therapy Keytruda (pembrolizumab).