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Breakthrough lung cancer drug gets MHRA green light

A cutting-edge treatment for lung cancer patients has provisionally been given the green light in the UK, meaning NHS patients will be the first in Europe to be offered it.

Sotorasib, which is taken as a tablet and is marketed as Lumykras, was granted a conditional marketing authorisation by the MHRA on Friday. It targets KRAS G12C, a mutation found in a quarter of all tumours, and has been shown to permanently lock it in an inactive state and prevent cell growth, says manufacturer Amgen UK.  

The NHS will begin offering the drug to eligible lung cancer patients within weeks through an early access agreement with Amgen, while NICE completes its appraisal process.

The announcement follows a 40-year search for a treatment for KRAS G12C. It has been approved as part of Project Orbis, an international programme between the US FDA and other regulatory agencies aimed at speeding up the review of new oncology medicines.

Described as the first drugof its kind, it is hoped that sotorasib could offer a breakthrough in the treatment of other deadly cancers including pancreatic and colorectal cancers.

Dr. Tony Patrikios, executive medical director at Amgen UK and Ireland, said: “Today’s conditional marketing authorisation by the MHRA marks an important moment in treating lung cancer patients, with a new targeted therapy, who have failed first-line treatment and face extremely poor outcomes with limited further treatment options.

“This reflects the clinical investigation programme, demonstrating the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.”

“Sotorasib is the first targeted KRAS G12C inhibitor to be authorised for use in Great Britain. Targeting KRAS has been a 40-year quest by scientists and researchers around the World. Approximately 13 per cent of patients with NSCLC harbour the KRAS G12C mutation and whilst approximately 48,000 people are diagnosed with lung cancer every year in the UK  it is estimated that 5,000 of these people will have KRAS G12C-mutated NSCLC.”

Professor Charles Swanton, Cancer Research UK’s chief clinician, said: “Sotorasib is one of the most exciting breakthroughs in lung cancer treatment in 20 years, targeting a cancer gene that was previously untargetable and built on decades of laboratory research that’s unravelled cancer’s inner workings.

“This medicine expands our list of effective precision therapies in lung cancer that are helping to improve survival for patients with limited options. It’s great news that patients in England will now benefit from this novel treatment.”




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