Green light for Amgen’s KRAS inhibitor in the UK

Amgen’s first-in-class KRAS inhibitor sotorasib has been approved in the UK under a deal between the drug maker and NHS England. The drug – known as Lumakras in the US and Lumykras in the UK – will be available initially to treat 600 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation.

This means patients in the UK will be the first in Europe to gain access to the drug, as the European Medicines Agency has yet to make a recommendation.

“The cutting-edge therapy sotorasib will be fast-tracked to NHS patients after being proven in clinical trials to stop lung cancer growing for seven months,” said NHS England. “The drug’s adoption by NHS follows a 40-year search for a treatment for the mutation on the KRAS gene, present in a quarter of all tumours.”

The decision was welcomed by cancer charity, Cancer Research UK, which estimates there are around 48,000 diagnoses of lung cancer in the UK each year. “Sotorasib is one of the most exciting breakthroughs in lung cancer in 20 years,” said the charity’s chief clinician, Professor Charles Swanton. “This medicine expands our list of effective precision therapies in lung cancer that are helping to improve survival for patients with limited options.”

Sotorasib was approved in the US in May, where it is priced at $17,900 per month or around $215,000 per year, a similar price to many other targeted cancer drugs.

KRAS mutations are present in around a quarter of NSCLC tumours, while KRAS G12C mutations are found in around 13% of cases, which tend to be more aggressive tumours. While KRAS has been a focus of research for nearly 40 years, it has proved one of the most challenging therapeutic targets in cancer research.

The approval is the second drug licensed in the UK through Project Orbis, the international partnership between medicines regulators in the UK, US, Australia and others, to speed up the approval process for promising cancer treatments.

In response to the announcement of the early access scheme, cancer charity Breast Cancer NOW has criticised Gilead for failing to follow suit with Trodelvy (sacituzumab govitecan) in triple negative incurable secondary breast cancer.

“Gilead’s proposed pre-reimbursement access scheme falls alarmingly short of what’s needed and will not guarantee all eligible women access to Trodelvy,” said the charity’s head, Baroness Delyth Morgan. “These women don’t have time to wait. Gilead must urgently do the right thing for breast cancer patients by reaching an agreement with NHS England so that all eligible women are granted access to Trodelvy without delay.”