• Osimertinib will be made available via the Cancer Drugs Fund (CDF) to patients in England with completely resected early-stage IB-IIIA EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).1
  • Currently, patients with this type of lung cancer are treated with the intention of cure; however, many relapse because treatment is limited to surgery and adjuvant chemotherapy.2
  • Unprecedented data from the ADAURA clinical trial show that osimertinib, the first approved targeted oral therapy in this setting, can reduce the risk of disease recurrence or death (disease-free survival) by 80% in patients with stage IB-IIIA EGFRm NSCLC versus placebo.3

AstraZeneca today announced that Tagrisso (osimertinib) is now available as an adjuvant treatment option after complete tumour resection in adult patients in England with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations via the Cancer Drugs Fund (CDF).1 Treatment with osimertinib is subject to a three-year clinical stopping rule.1 This follows a positive final recommendation from the National Institute for Health and Care Excellence (NICE).

Professor Eric Lim, Professor of Thoracic Surgery at The Royal Brompton Hospital, said: “This is a significant milestone in the treatment of lung cancer in England as there remains an urgent need for new personalised therapies even in early-stage disease that have the potential to improve results of established treatments such as surgery. Data show that osimertinib, a well-tolerated treatment, reduces the risk of cancer recurrence or death by 80% in patients with early-stage EGFR mutation-positive non-small cell lung cancer after a successful operation. It is vital we identify eligible patients with EGFR mutations early in the treatment pathway to ensure they can access this treatment to potentially improve and extend their lives.”

Lung cancer accounts for over one in five (21%) of all cancer deaths in the UK,4 and more than 48,000 people in England are diagnosed with NSCLC every year,5 with around 12% having tumours with EGFR mutations.6 Patients with early-stage NSCLC often undergo surgery with curative intent as standard of care – however, disease recurrence within five years of surgery remains high, and has been reported to occur in 45% of Stage IB, 62% of Stage II, and 76% of Stage III patients.2

Jenny Abbott, co-chair of patient organisation EGFR Positive UK, said: “Early diagnosis, coupled with early preventative treatment, is key to improving long-term survival and we welcome this decision, which means that patients diagnosed in England with early-stage lung cancer will now continue to have access to this important potential life-extending treatment.”

In the ADAURA Phase III trial, adjuvant treatment (after surgery) with osimertinib in patients with stage II-IIIA EGFRm NSCLC reduced the relative risk of disease recurrence or death (disease-free survival) by 83% compared to placebo (HR = 0.17; 99.06% CI, 0.11 to 0.26; P<0.0011).3 Survival without disease recurrence at two years was 90% (95% CI 84-93) for osimertinib and 44% (95% CI 37-51) for placebo.3 When looking at the broader group of patients (stage IB-IIIA) – a secondary endpoint – the percentage of patients who were alive and disease-free at 24 months was 89% (95% CI, 85 to 92) in the osimertinib group and 52% (95% CI, 46 to 58) in the placebo group. The overall hazard ratio for disease recurrence or death was 0.20 (99.12% CI, 0.14 to 0.30; P<0.001), which equates to an 80% risk reduction.3

The announcement follows authorisation of a license extension by the Medicines and Healthcare products Regulatory Agency (MHRA) in May for osimertinib as monotherapy in this indication – the first authorisation issued under Project Orbis; a global programme designed to deliver faster patient access to innovative cancer treatments.7 Simultaneously, an agreement was reached with NHS England and NICE to enable early access to osimertinib for patients in England. The NICE recommendation announced today means that patients will continue to be eligible for treatment with osimertinib via the Cancer Drugs Fund.1

Tom Keith-Roach, President, AstraZeneca UK, said: “The Government’s Life Sciences Vision recognises how integral early diagnosis and rapid access to innovative medicines are for improving outcomes for people with cancer, and the chain of events leading to today’s NICE recommendation is testament to this. From the MHRA, to NICE and NHS England, we welcome the collaborative engagement that has enabled us to bring the first precision medicine for early-stage lung cancer to patients as quickly as possible.”

Arun Krishna, Head of Oncology, AstraZeneca UK, said: “We are delighted with this positive recommendation which builds on the initial early access authorisation achieved through Project Orbis and reaffirms the role that this potentially life-extending treatment can have for some people with early-stage lung cancer. It’s now critical that everyone with non-small cell lung cancer – no matter what stage of disease – is tested for the presence of EGFR mutations to determine whether osimertinib could be a potential treatment option.”

Across the ADAURA, FLAURA and AURA studies for osimertinib, very common adverse reactions included: diarrhoea (47% all grades; 1.4% > grade 3), stomatitis (24% all grades; 0.5% > grade 3), rash (45% all grades; 0.7% > grade 3), dry skin (32% all grades; 0.1% > grade 3), paronychia (33% all grades; 0.4% > grade 3), pruritus (17% all grades; 0.1% > grade 3), platelet count decreased (53% all grades; 1.2% > grade 3), leucocytes decreased (65% all grades; 1.2% > grade 3), lymphocytes decreased (62% all grades; 6.1% > grade 3) and neutrophils decreased (33% all grades; 3.2% > grade 3).8 Common adverse reactions included: epistaxis (5.3% all grades; 0 > grade 3), interstitial lung disease (3.7% all grades; 1.1% > grade 3), Palmar-plantar erythrodysaesthesia syndrome (1.7% all grades; 0 > grade 3), alopecia (4.6% all grades; 0 > grade 3), urticaria (1.9% all grades; 0.1% > grade 3) and blood creatinine increased (9.4% all grades; 0 > grade 3).8


About osimertinib

Osimertinib monotherapy is licensed in the United Kingdom for:

  • the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
  • the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations
  • and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. 8

Osimertinib was discovered and developed in the UK by AstraZeneca scientists. It is a third generation, orally administered EGFR TKI, a targeted therapy for advanced EGFR mutation-positive NSCLC.

In normal cells, EGFR plays a central role in regulating cell division and death; however, mutations in the EGFR can cause excessive cell growth and division. Osimertinib works by binding to the mutated EGFR thereby blocking the cell signalling pathway that drives the growth of tumour cells in NSCLC.9

For more information about osimertinib, a summary of product characteristics (SMPC) can be found here: https://www.medicines.org.uk/emc/product/1985/smpc.


The license for osimertinib in early-stage NSCLC is based on data from ADAURA – a randomised, double-blind, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II and IIIA EGFR mutation-positive NSCLC following complete tumour resection and adjuvant chemotherapy as indicated. Patients were treated with osimertinib 80mg once-daily oral tablets or placebo for three years or until disease recurrence.

The trial enrolled patients in more than 185 centres across 24 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint was DFS in Stage II and IIIA patients and a key secondary endpoint was DFS in Stage IB, II and IIIA patients.

The data readout was originally anticipated in 2022. In April 2020, an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early based on a determination of overwhelming efficacy. Investigators and patients continue to participate and remain blinded to treatment. The trial will continue to assess overall survival.

About lung cancer

Lung cancer is the most common cause of cancer death in the UK, accounting for one in five (21%) of all cancer deaths.4 NSCLC is the most common type – more than 48,000 people in England are diagnosed with NSCLC every year,5 with around 12% having tumours with EGFR mutations.6 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells.9 Approximately 25-30% of patients with NSCLC present with resectable disease at diagnosis.10,11,12

The UK has one of the worst five-year survival rates for lung cancer in Europe.13


AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca is based in five different locations across the UK, with its global headquarters in Cambridge. In the UK, around 8,300 employees work in research and development, manufacturing, supply, sales and marketing. We supply 40 different medicines to the NHS.

For more information, please visit www.astrazeneca.co.uk and follow us on Twitter @AstraZenecaUK.


  1. National Institute for Health and Care Excellence. Final Appraisal Document. Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection. Issue date: 30 November 2021.
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  3. Wu YL, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non–small-cell lung cancer. N Engl J Med. 2020;383:1711-1723.
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  9. Cross DA, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4:1046-1061.
  10. Cagle PT, Allen TC, Olsen RJ. Lung cancer biomarkers: present status and future developments. Arch Pathol Lab Med. 2013;137:1191–1198.
  11. Datta D, Lahiri B. Preoperative evaluation of patients undergoing lung resection surgery. Chest. 2003;123:2096–2103.
  12. Le Chevalier T. Adjuvant chemotherapy for resectable non-small-cell lung cancer: where is it going? Ann Oncol. 2010;21:196–198.
  13. Allemani C, et al. Global surveillance of trends in cancer survival: analysis of individual records for 37,513,025 patients diagnosed with one of 18 cancers during 2000–2014 from 322 population-based registries in 71 countries (CONCORD-3). Lancet. 2018 March 17; 391(10125): 1023–1075. doi:10.1016/S0140-6736(17)33326-3.

UK Media Enquiries Emma White, AstraZeneca: 07385 516437 / emma.white1@astrazeneca.com Alex Larkinson, Edelman: 07980 687255 / alex.larkinson@edelman.com