Lung cancer cellLung cancer cell. Credit: LRI EM Unit.

More than 600 people in England with a form of lung cancer could benefit from the innovative drug osimertinib (Tagrisso) after its approval by the National Institute for Health and Care Excellence (NICE).

The drug will now be available to people with early-stage non small cell lung cancer (NSCLC) who have had surgery to remove their tumour that has errors in a gene called EGFR.

Evidence currently suggests that the drug could reduce the risk of their cancer coming back after surgery by 80%. However, this data is still being collected so the full extent of its effectiveness is uncertain.

This decision means people with this form of lung cancer will be able to have osimertinib on the NHS through the Cancer Drugs Fund, which helps provide access to promising medicines, while further evidence is gathered on its clinical and cost-effectiveness.

“I am delighted we are able to recommend osimertinib within the Cancer Drugs Fund for people with this type of lung cancer,” said Professor Gillian Leng, chief executive at NICE. “Osimertinib shows real potential in being able to stop people’s cancer from reccurring following surgery.”

Reducing the risk of cancer coming back

Surgery is the preferred treatment for many people with early-stage NSCLC as it can potentially be a cure. However, the chances of the disease coming back within 5 years of surgery is high – even for those whose cancer is at one of the earliest stages, nearly half will have their disease return.

Whilst chemotherapy is offered to these patients to help prevent their disease from coming back, it only provides minimal benefit whilst having side effects, so many people decline it.

Osimertinib is the first targeted treatment for these patients that has potential to give real benefit. The drug is also a pill that can be taken at home, rather than having to visit a hospital.

“For people at this stage of their cancer treatment and with this type of lung cancer, treatment options are extremely limited. Osimertinib is a promising treatment in a new place in the treatment pathway and today’s decision will be welcome news for them and their families,” said Leng.

Targeting a common DNA mutation

Osimertinib works by blocking a molecule made by the EGFR gene. This molecule helps cells in the body to grow. An error in the gene for EGFR can cause cells to grow too much, which can cause cancer.

Blocking this molecule in people whose tumours have an error in EGFR can then help to slow or stop their lung cancer from growing or coming back.

Around 1 in 10 people with lung cancer in the UK have an error in EGFR. According to NICE, there are around 600 people in England who would be eligible for treatment with osimertinib.

Current evidence from the ADAURA clinical trial shows that compared to just monitoring the patients, treatment after surgery with osimertinib reduces the risk of the disease coming back by 80%. It may also lower the risk of people dying from their cancer.

However, this evidence is uncertain because information from the trial was released early. For this reason, the drug is recommended for use within the Cancer Drugs Fund rather than in routine NHS commissioning.

Drugs approved by NICE for use through the Cancer Drug Fund in England are normally considered in Northern Ireland in line with existing arrangements for endorsement of NICE recommendations.

If further data shows that osimertinib works well and is cost-effective, the drug will be considered for routine use in the NHS. If approved by NICE for use in England, this decision will likely then be adopted in Wales and Northern Ireland, while Scotland has a separate process for reviewing drugs.

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