NHS fast tracks access to Amgen's just-approved KRAS cancer drug

Amgen's first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE.

The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and according to Amgen patients in England, Wales and Scotland will be the first in Europe to receive the drug.

The NHS will begin to offer the drug to eligible lung cancer patients "within weeks", according to the drugmaker, including approximately 600 lung cancer patients in England.

Amgen filed Lumykras in the EU last December, but the European Commission hasn't yet approved it, so patients in Northern Ireland – which remains under the EU regulatory framework – will have to wait for access for a while.

Sotorasib was approved in the US as Lumakras in May, becoming the first KRAS drug to reach the market after decades of R&D effort to find a compound that could hit the elusive target, long considered "undruggable."

In the US, Amgen has priced Lumakras at $17,900 per month – equivalent to around $215,000 per year – which is in the same ballpark as many other targeted cancer drugs. Analysts think the product could easily achieve sales of $1 billion or more, particularly if it can move not first-line therapy and other KRAS-mutated tumours.

KRAS mutations are seen in around a quarter of NSCLC tumours, with KRAS G12C mutations in particular found in around 13% of cases, and tend to be found in more aggressive tumours.

In the phase 2 CodeBreaK 100 trial that underpinned the approval, 37.1% of patients treated with Lumykras responded to the drug, with 80.6% achieving control of their disease with growth of tumours halted by around seven months.

NHS England has agreed a number of other early access deals, notably including Novartis' cholesterol lowering Leqvio (inclisiran) that can be doses once every six months, and AstraZeneca's lung cancer therapy Tagrisso (osimertinib).

Lumykras is also the first new cancer medicine to be approved under Project Orbis, a global project run by the FDA and other regulators including the MHRA that aims to allow patients faster access to innovative cancer treatments.

Cancer Research UK estimates there are around 48,000 new lung cancer cases in the UK every year, making it the country's third most common form of cancer.

Professor Charles Swanton, CRUK's chief clinician, said: "Sotorasib is one of the most exciting breakthroughs in lung cancer in 20 years. This medicine expands our list of effective precision therapies in lung cancer that are helping to improve survival for patients with limited options."

Call for Gilead to follow suit with Trodelvy

The approval and early access agreement has been hailed by cancer charity Breast Cancer NOW, which has called on Gilead Sciences to agree a similar access deal with the NHS for its Trodelvy (sacituzumab govitecan) therapy for incurable triple-negative breast cancer (TNBC).

"If Gilead fails to do this, hundreds of women who face short prognoses and limited treatment options could have an agonising wait of up to eight months until a decision about routine use of Trodelvy on the NHS is made," said the charity's chief executive Baroness Delyth Morgan.