An innovative life-extending drug for treating mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults is being recommended by NICE as an option for use within the Cancer Drugs Fund.

NICE has today (Thursday, 3 March) published its final appraisal document on sotorasib (also known as Lumykras and made by Amgen), a once-a-day tablet, which is being recommended for people with the KRAS G12C gene mutation of non-small-cell lung cancer who have progressed on, or are intolerant to, platinum-based chemotherapy and/or immunotherapy.

Over 500 people in England are eligible to receive this treatment in 2022, which is the first active new technology to come through the Innovative Licensing and Access Pathway (ILAP) and receive a positive recommendation from NICE.

Lung cancer is the third most common cancer in the UK, with over 48,000 new cases diagnosed each year, and KRAS is the most commonly mutated gene in lung cancer.

NSCLC accounts for around 85% of all lung cancers and KRAS G12C is the most commonly mutated gene in NSCLC, occurring in 12% of NSCLC tumours in the UK.

The current treatment for NSCLC is platinum-based chemotherapy and/or immunotherapy and sotorasib can be used after chemotherapy. There were previously no targeted treatment options for the KRAS G12C mutation and a poor prognosis for patients.
 

Helen Knight, programme director in the Centre for Health Technology Evaluation at NICE, said: “We are determined to continue providing people with early access to innovative treatments, such as sotorasib, which has the potential to not only extend the lives of those with the KRAS G12C gene mutation of non-small-cell lung cancer but improve their quality of life.

“Results from trial data suggest that, after platinum-based chemotherapy, sotorasib, which is the first targeted treatment for the KRAS G12C gene mutation, increases the time before the cancer gets worse and how long people live compared with current treatments.

“Our committee found there was a lack of suitable targeted treatments for KRAS G12C mutation-positive locally advanced or metastatic NSCLC, and that sotorasib has the potential to deliver physical and psychological benefits to patients.

“While sotorasib cannot be recommended for routine use in the NHS at this stage it is being recommended for use in the Cancer Drugs Fund so that further direct comparative data, long-term evidence and information around cost effectiveness can be collected and reassessed by NICE in the future.”
 

A confidential price discount has been agreed between NHS England and Improvement and the company, through a managed access agreement, and the treatment is available to patients from today.