MHRA approval for AZ’ Tagrisso under Project Orbis

MHRA approval for AZ' Tagrisso under Project Orbis

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a license extension for AstraZeneca’s Tagrisso (osimertinib) in Great Britain, for use as monotherapy 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 (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.4 This is the first authorisation to be issued by the MHRA under Project Orbis, a collaborative, global programme designed to deliver faster patient access to innovative cancer treatments.1

An agreement with NHS England and the National Institute for Health and Care Excellence (NICE) will enable early access to Tagrisso for all patients in England with this specific type of lung cancer. Access is given ahead of official NICE guidance to ensure patients have the chance to benefit from this new treatment option as soon as possible. NICE guidance is not expected to be published until September 2021 at the earliest.5

Dr Carles Escriu, Consultant in Thoracic Medical Oncology at The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool, said: “Today’s news is potentially practice-changing because, for the first time, we have access to a targeted treatment for early-stage lung cancer. Osimertinib is a well-tolerated, once-daily tablet treatment and data show that, when taken after surgery, it can reduce the risk of disease recurrence or death by 80% after two years of treatment in patients with Stage IB-IIIA non-small cell lung cancer who have an EGFR mutation. Early-stage lung cancer patients can now be tested for EGFR mutations to give them the chance of delaying the return of cancer after surgery.”

Arun Krishna, Head of Oncology, AstraZeneca UK, said: “Patients diagnosed in the earlier stages of EGFR mutation-positive non-small cell lung cancer have the best chance of living disease-free, but many see their cancer return. Osimertinib, which was discovered by AstraZeneca scientists in the UK, could significantly improve patient outcomes in a disease setting that has had no new treatment options in over a decade. With this in mind, we have worked with urgency to secure the MHRA license and access in England to bring this treatment option to patients as quickly as possible. We will continue to work with authorities in the other nations of the UK to secure patient access at the earliest opportunity.”


  1. UK. Guidance on Project Orbis: what the Project Orbis initiative is and MHRA involvement in this regulatory path. Available at: Last accessed: May 2021.
  2. Pignon JP, Tribodet H, Scagliotti GV, et al. Lung Adjuvant Cisplatin Evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.
  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.
  4. Tagrisso (osimertinib). Summary of Product Characteristics. 1 October 2020. Available at: Last accessed: May 2021
  5. Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection [ID3835]. Project information. Available at: Last accessed: May 2021