Fifth drug to be licensed under project orbis approved for routine NHS use
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UK: Fifth drug to be licensed under Project Orbis approved for routine NHS use 


The fifth oncology drug to be licensed under the Project Orbis initiative has been approved for routine use in the national health service (NHS) in England by the National Institute for Health and Care Excellence (NICE). Merck Serono’s Tepmetko (tepotinib) is approved as an option for treating advanced non-small-cell lung cancer with METex14 skipping gene alterations in adults. According to NICE, just over 700 patients in England will be eligible to receive the drug as a first or second-line treatment. NICE notes that a confidential price discount has been agreed between NHS England and Improvement and the manufacturer through a commercial access agreement to ensure the treatment could be made available to patients.  

The Project Orbis initiative is an international partnership between medicines regulators in the UK, US, Australia, Brazil, Canada, Singapore and Switzerland and is designed to speed up the approval process for promising cancer treatments. Amgen’s Lumykras (sotorasib), AstraZeneca’s Tagrisso (osimertinib), Roche’s Tecentriq (atezolizumab) and Takeda’s Exkivity (mobocertinib) have all also received approval under the Project Orbis initiative.  

Source:, “Over 700 people a year could benefit from a new potentially life-extending lung cancer drug which targets a specific genetic mutation”, 14th April 2022 

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