The National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending Amgen’s Lumykras (sotorasib) for treatment use within the Cancer Drugs Fund.
It will be available as an option for adult patients diagnosed with the KRAS G12C mutation-positive locally advanced, or metastatic non-small-cell lung cancer (NSCLC) patients, whose disease has progressed on – or who cannot tolerate platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy – in line with the managed access agreement.
Lumykras – an oral targeted therapy – is Amgen’s first-in-class drug and was the first new medicine to receive a Conditional Marketing Authorisation (CMA) from the Medicines and Healthcare products Regulatory Agency (MHRA) for use across England, Scotland and Wales under Project Orbis.
The treatment will now be available to eligible patients in England through the Cancer Drugs Fund, which will address an unmet need in previously treated patients with KRAS G12C NSCLC – a mutation which was previously thought to be ‘undruggable’.
With an estimated 48,000 new cases diagnosed in the UK every year, lung cancer is recorded as being the third most common cancer, while NSCLC accounts for around 85% of lung cancers and approximately 13% of these are believed to carry the KRAS G12C mutation.
NICE’s decision to grant a recommendation for Lumykras for use in the Cancer Drugs Fund follows a deal between Amgen and NHS England, which has already allowed over 100 patients to gain access to the treatment following its CMA by MHRA through Project Orbis.
The CMA for Lumykras is based on clinical evidence from the phase 2 CodeBreaK 100 trial which evaluated the drug in 126 patients with KRAS G12C- mutated advanced NSCLC.
Dr Tony Patrikios, executive medical director at Amgen UK and Ireland, said: “Sotorasib provides a new treatment option for appropriate patients whose lung cancer is found to have the KRAS G12C mutation. More than half of NSCLC patients have advanced or metastatic disease at diagnosis and outcomes across the UK remain poor.”
Paula Chadwick, chief executive of Roy Castle Lung Cancer Foundation, commented: “The pandemic has had a devastating effect on these patients, potentially denying many of them the chance of an earlier and possibly life-saving diagnosis. However, the advances in new treatments like sotorasib offer some hope by giving people another treatment option.”