Amgen's Lumykras recommended by NICE for NSCLC

Today, US biotech giant Amgen’s (Nasdaq: AMGN) first-in-class medicine, Lumykras (sotorasib), has been recommended by the UK’s National Institute for Health and Care Excellence (NICE), following an accelerated marketing authorization through Project Orbis last year.

The health technology assessor published a final appraisal document recommending Lumykras for use within the Cancer Drugs Fund as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy, in accordance with the managed access agreement.

Amgen’s first-in-class drug, sotorasib, was the first new medicine to receive a Conditional Marketing Authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) for use across England, Scotland and Wales under Project Orbis. The treatment, an oral targeted therapy, will now be available to suitable patients in England via the Cancer Drugs Fund, addressing an unmet need in previously treated patients with KRAS G12C NSCLC, a mutation which was previously thought to be “undruggable.”