The MHRA has now approved the effective therapy, atezolizumab, to treat non-small cell lung cancer (NSCLC), with more than 850 patients in England expected to be eligible for the drug in the first year, rising to more than 1000 in the third year.
Atezolizumab is the first immunotherapy approved for patients with early-stage NSCLC whose tumours express the PD-L1 mutation, and who have undergone surgery and chemotherapy. These patients are at risk of their cancer returning, and England is only the second country in Europe to make this cutting-edge treatment available.
Clinical trials have shown atezolizumab (Tecentriq) can significantly reduce the risk of cancer recurrence or death by 34% in people with early-stage NSCLC, following surgery and chemotherapy.
Given as an IV drip, this innovative treatment works by blocking a protein that stops the immune system from attacking cancer cells, by making cancer cells more visible to the immune system.
The first patients will be able to receive treatment in the next few weeks, while the National Institute for Health and Care Excellent (NICE) completes its ongoing appraisal after an early-access deal was struck by NHS England with the manufacturer, Roche.
Amanda Pritchard, chief executive of NHS England, said: “I’m delighted that the NHS in England has secured this deal so we can continue to offer patients the best in cutting-edge drugs and state-of-the-art treatments. By making atezolizumab available at the earliest opportunity NHS patients now have a very exciting new treatment which has the potential to dramatically reduce their risk of cancer relapse.
“The NHS has a strong track record of securing rapid access to innovative, trailblazing treatments for our patients, and this is the latest agreement that places a brand new treatment in the hands of frontline NHS staff, supporting them to continue to deliver world-class patient care.
“The NHS Long Term Plan set out an ambition that 55,000 more people will survive their cancer each year, and this treatment is great news for patients whose lung cancer is picked up early by the Targeted Lung Health Checks pilot which is another pioneering initiative spear-headed by the NHS”.
Health and Social Care Secretary Sajid Javid said: “The UK is renowned for its ability to find and deploy the most innovative treatments the world has to offer to NHS patients.
“This breakthrough will be life-changing for hundreds of people and marks a significant development in our war on cancer.
“A big thank you to NHS England, Roche, the MHRA and the teams of scientists and medical experts who have made this life-saving deal a reality.”
Lung cancer is the most common cause of cancer death in the UK, accounting for around a fifth of all cancer deaths.
Professor Charles Swanton, Cancer Research UK’s chief clinician, said: “It’s great to see this drug approved so quickly, bringing even more optimism to tackling a difficult to treat cancer.
“Sadly, early-stage lung cancers often come back after surgery, especially larger tumours, and the approval of atezolizumab treatment for PD-L1+ non-small cell lung cancer is a major step forward as a follow up treatment after surgery and chemotherapy.
“Atezolizumab will help to dramatically reduce the risk of tumours coming back and increase the chance of curing the disease long term – allowing patients to return to normal life.”
This is the third drug which has been made available by the NHS in England through an early national access agreement following a Project Orbis licence, following similar NHS agreements for osimertinib and cutting-edge therapy Sotorasib, which targets the so-called “death star” mutation.
Dame June Raine, MHRA Chief Executive, said: “Through the MHRA’s membership of Project Orbis, an innovative programme coordinated by the US Food and Drug Administration (FDA) with other regulators across the world, we are working to ensure that patients receive earlier access to promising cancer treatments.
“Following our rigorous review, Tecentriq can now be prescribed to more patients suffering with lung cancer, enabling the NHS to extend patient access to this life-saving treatment.”
Gemma Boni, Head of Lung Cancer, Roche Products Limited said: “We are delighted that patients treated with early stage non-small cell lung cancer in England will now have access to this treatment option.
“This decision further underscores the significant benefit offered by immunotherapies in cancer treatment and contributes to the fight against cancer.”
Project Orbis is an international partnership between medicines regulators in the UK, U.S., Australia and others, set up to speed up the approval process for promising cancer treatments.
England is the second European country to make this drug available, after Switzerland who are also a member of Project Orbis.