The NHS announced Friday that patients with lung cancer in England will be the first in Europe to be offered Amgen's Lumakras (sotorasib), an oral treatment that targets KRAS mutations. The health service estimated that roughly 600 NHS lung cancer patients a year will be given the drug, newly approved by the Medicines and Healthcare products Regulatory Agency (MHRA), starting in the next few weeks.
Previously known as AMG 510, the drug will be fast-tracked to NHS patients after being shown in clinical trials to stop lung cancer growing for seven months, it added. Blake Dark, interim chief commercial officer at the NHS, noted that an agreement with Amgen will permit early access to Lumakras for eligible patients on a "budget-neutral basis" to the NHS, while NICE completes its ongoing appraisal. The drug-pricing watchdog is evaluating the clinical and cost effectiveness of Lumakras for previously treated KRAS G12C-mutated non-small-cell lung cancer (NSCLC), with a decision scheduled for March 2022.
US regulators granted Lumakras an accelerated approval in May for the same indication, based on data from the CodeBreaK 100 study. That decision made Lumakras the first treatment for lung cancer targeting KRAS mutations, which were previously considered to be resistant to drug therapy. Amgen is also seeking regulatory approval of the drug in Europe, Japan and several other markets.
Meanwhile, this is the latest rapid-access scheme entered into by NHS England, following a similar agreement in May for AstraZeneca's Tagrisso (osimertinib) to treat NSCLC in patients who have just had surgery and whose tumours have a specific type of genetic mutation.
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