UK’s MHRA approves Amgen’s sotorasib for non-small cell lung cancer

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Amgen’s sotorasib (Lumakras) to treat patients with specific non-small cell lung cancer with KRAS G12C mutation.

To be taken as a tablet, sotorasib binds with the KRAS G12C mutation and stops cell division as well as the cancer growth.

The National Health Service (NHS) will start offering the new drug to eligible lung cancer patients in England within weeks after reaching an agreement with Amgen and the National Institute for Health and Care Excellence (NICE) to provide it on a budget-neutral basis.

The MHRA approval is based on the project Orbis, an international partnership between health regulators in the US, UK, Australia, and other countries that aims to accelerate the approval process for cancer treatments.

Sotorasib is the second drug to become available to the NHS in England through project Orbis.

In May this year, the NHS approved AstraZeneca’s Osimertinib (Tagrisso) to treat patients with mid and later stage non-small cell lung cancer (NSCLC) with EGFR mutation.

NHS Cancer Clinical Director Peter Johnson said: “The NHS is committed to saving more lives from cancer through better diagnosis and treatment, with molecular testing through our genomics programme increasingly important for selecting the best options for patients.

“This revolutionary treatment has taken decades of research to reach the clinic, and now that it is here this new targeted drug will be available for eligible people with lung cancer as quickly as possible thanks to this agreement.”

The NHS estimates that approximately 600 lung cancer patients per year will be initially eligible for the treatment with sotorasib in England.