MHRA issues its first authorisation under Project Orbis for osimertinib
The license for osimertinib, currently for the treatment of locally advanced and metastatic NSCLC with activating EGFR mutations, has been extended to include adjuvant treatment of early-stage disease. Early access on the NHS has been agreed while NICE undertakes an appraisal.
Source:
Medicines and Healthcare products Regulatory Agency
SPS commentary:
Project Orbis is a programme coordinated by the US Food and Drug Administration involving Canada, Australia, Switzerland, Singapore Brazil and the UK, to review and approve promising cancer treatments quickly and efficiently. The UK joined the scheme in January 2021.
NHS England, NICE and AstraZeneca have reached an agreement to enable early access to osimertinib for early-stage lung cancer patients in England on a budget-neutral basis to the NHS while NICE undertakes its appraisal.
An NHS England press release notes that around 100 people in England will initially have access to osimertinib, with many more expected to benefit this year.