MHRA approves Lumykras for patients with previously treated metastatic NSCLC with KRAS G12C mutation and early access is granted to the NHS.-Amgen

KRAS mutations are seen in around a quarter of NSCLC tumours, with KRAS G12C mutations in particular found in around 13% of cases, and tend to be found in more aggressive tumours. In the phase II CodeBreaK 100 trial that underpinned the approval, 37.1% of patients treated with Lumykras responded to the drug, with 80.6% achieving control of their disease with growth of tumours halted by around seven months.

Lumykras is also the first new cancer medicine to be approved under Project Orbis, a global project run by the FDA and other regulators including the MHRA that aims to allow patients faster access to innovative cancer treatments.

NHS England, NICE (National Institute for Health and Care Excellence) and manufacturer Amgen have reached an agreement to enable early access to sotorasib for eligible lung cancer patients in England on a budget-neutral basis to the NHS while NICE completes its ongoing appraisal.