A new lung cancer drug that stops tumours growing by targeting the so-called “death star” mutation has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
The first-of-its-kind cancer drug Sotorasib (Lumykras) will be fast-tracked to NHS patients after being proven in clinical trials to stop lung cancer growing for seven months.
The drug’s adoption by the NHS follows a 40 year search for a treatment for the mutation on the KRAS gene, present in a quarter of all tumours, which has been dubbed the “Death Star” because of its spherical appearance and impenetrable nature.
The NHS in England will begin to offer the drug within weeks to eligible lung cancer patients, following a national access agreement reached with the manufacturer.
Most exciting breakthrough in lung cancer in 20 years
Sotorasib has been licenced to treat adults with non small cell lung cancer that carries a specific genetic fault known as the KRAS G12C mutation. It will be an option for patients whose tumours have begun to spread and who have already been treated with platinum-based chemotherapy and/or immunotherapy.
Around 600 NHS patients a year in England are expected to benefit from the tablet.
Professor Charles Swanton, Cancer Research UK’s chief clinician, said: “Sotorasib is one of the most exciting breakthroughs in lung cancer 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.”
Around one in four cancers are driven by faulty RAS proteins. These faults are commonly found in several hard-to-treat cancers, including pancreatic, lung and bowel tumours.
People taking the drug lived without their tumour growing for seven months on average. The trial didn’t compare the drug with any currently available treatments, but the researchers noted that those taking standard treatments (chemotherapy) in other trials have lived without their tumour growing for less than four months on average.
Treatment-related adverse events occurred in 88 patients, with the most common being diarrhoea, nausea and fatigue.
Swanton said: “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.”
Rapid access for hundreds of patients
Interim NHS Chief Commercial Officer, Blake Dark, said that after 40 years of scientific research, this drug marks “a major breakthrough in cancer treatment, which is why the NHS has worked to secure rapid access to treatment for hundreds of eligible lung cancer patients”.
Sotorasib was approved through project Orbis – a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments. It’s the second drug to be approved through project Orbis, which includes the regulatory authorities of Canada, Australia, Switzerland, Singapore, Brazil and, as of January 2021, the UK.
The drug will be available for NHS use within weeks after NHS England, NICE and manufacturer Amgen reached an agreement to enable early access to eligible lung cancer patients in England on a budget-neutral basis to the NHS, as NICE completes its ongoing assessment.
Final NICE guidance is expected in March 2022. NICE decisions are usually adopted in Wales and Northern Ireland, while Scotland has a separate process for reviewing drugs.