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UK's MHRA Grants Early Access to Amgen's Lumakras for KRAS-Mutant Lung Cancer

NEW YORK – The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) on Friday approved Amgen's sotorasib (Lumakras) for advanced non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation.

The National Health Service (NHS) will begin offering the drug to lung cancer patients in England after reaching an agreement with Amgen and the UK's cost-effectiveness analysis body National Institute for Health and Care Excellence (NICE) to provide it on a budget-neutral basis. NICE is still conducting an economic appraisal, which is necessary to convert the conditional approval into full approval.

The drug was quickly approved by MHRA based on data shared through Project Orbis, an international partnership between health regulators in the UK, US, Australia, and other countries aimed at speeding up access to innovative drugs around the world. Sotorasib is the second cancer drug to become available to the NHS through Project Orbis. Earlier this year, the NHS approved osimertinib (AstraZeneca's Tagrisso) for EGFR-mutated early-stage non-small cell lung cancer.

The approval in England comes just more than three months after its approval by the US Food and Drug Administration. Sotorasib was approved in the US in May for previously treated patients with locally advanced or metastatic non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation.

"The NHS is committed to saving more lives from cancer through better diagnosis and treatment, with molecular testing through our genomics program increasingly important for selecting the best options for patients," Peter Johnson, NHS clinical director for cancer, said in a statement. "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 about 600 patients each year will be eligible for treatment with sotorasib.