Amgen’s Lumykras gains MHRA approval under Project Orbis

Amgen’s Lumykras gains MHRA approval under Project Orbis

Amgen’s first-in-class medicine Lumykras (sotorasib) has become the first new cancer therapy to receive Conditional Marketing Authorisation for use1 across England, Scotland and Wales by the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.

The authorisation follows a review of sotorasib’s role in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C gene mutation.

Sotorasib, which is administered orally as a tablet formulation5, binds with a mutated KRAS G12C protein to ‘switch off’ the signals it sends to trigger cell division and cancer cell growth3. Sotorasib has been shown to irreversibly bind to the inactive KRAS G12C protein, permanently locking it in an inactive state, leading to inhibition of cancer cell growth3, 6-8.

The MHRA review of sotorasib centred around the Phase II CodeBreaK 100 clinical study which evaluated sotorasib in 126 patients with KRAS G12C-mutated advanced NSCLC. Patients were treated with sotorasib 960 mg once daily orally, and prior to the trial, patients had progressed on platinum-based chemotherapy and/or PD1/PD-LI immunotherapy2.

Professor Sanjay Popat, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Lung cancer driven by the KRAS G12C mutation is a highly aggressive cancer when it has relapsed after standard treatments and sotorasib is a first-in-class medicine, allowing eligible patients to receive daily tablets rather than chemotherapy in the hospital. I’m therefore delighted to see this rapid MHRA Conditional Marketing Authorisation. Importantly, in parallel the NHS is making excellent progress in the molecular analysis of lung cancer patients to find the KRAS G12C mutation and identify those patients who are most likely to benefit from this treatment.”

Dr. Tony Patrikios, Executive Medical Director, Amgen UK and Ireland, said: “Today’s Conditional Marketing Authorisation by the MHRA marks an important moment in treating lung cancer patients, with a new targeted therapy, who have failed first-line treatment and face extremely poor outcomes with limited further treatment options. This reflects the clinical investigation programme, demonstrating the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy5.

“Sotorasib is the first targeted KRAS G12C inhibitor to be authorised for use in Great Britain. Targeting KRAS has been a 40-year quest by scientists and researchers around the World. Approximately 13% of patients with NSCLC harbour the KRAS G12C mutation3,10 and whilst approximately 48,000 people are diagnosed with lung cancer every year in the UK12,13 it is estimated that 5,000 of these people will have KRAS G12C-mutated NSCLC.”


  1. Amgen internal information.
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  13. Cancer Research UK. Types of Lung Cancer. Available at: Accessed August 2021.