Early access agreement
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UK: Early access agreement for Exkivity following Project Orbis approval


UK: Early access agreement for Exkivity following Project Orbis approval 

Patients in England will be the first in Europe to have access to Takeda’s Exkivity (mobocertinib), NHS England has announced. Under a deal brokered by NHS England, Exkivity will be made available in the national health service (NHS) to patients with non-small-cell lung cancer whose tumours have EGFR Exon 20 insertion mutations, who have already received chemotherapy, following approval by the Medicines and Healthcare Products Regulatory Agency (MHRA). According to NHS England, the drug will be made available on a “budget-neutral basis” while the National Institute for Health and Care Excellence (NICE) completes its ongoing appraisal of the drug. Around 100 patients will be eligible to receive the drug each year.  

This is the fourth drug (following Amgen’s Lumykras [sotorasib], AstraZeneca’s Tagrisso [osimertinib] and Roche’s Tecentriq [atezolizumab] to be made available in the NHS in England through an early national access agreement following approval under the Project Orbis initiative, an international partnership between medicines regulators in the UK, US, Australia, Brazil, Canada, Singapore, and Switzerland. The initiative is designed to speed up the approval process for promising cancer treatments.  


  1., “NHS fast tracks new ‘gamechanging’ drug for lung cancer”, 18th March 2022 
  2. www.pharmaphorum, “NHS grants fast-track access to Takeda’s lung cancer drug Exkivity”, 21st March 2022 

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