“UK gets new lung cancer drug under international scheme thanks to Brexit deal.”
“We looked it up. This drug is licensed for use in the EU. It’s been available to EU countries since 2016.”
A Daily Express headline says that the UK has authorised a “new lung cancer drug under international scheme thanks to [the] Brexit deal”. The Best for Britain campaign group has attempted to fact check the headline in posts on social media, claiming that it’s a ‘new low’ and that the drug has been licensed and available to EU countries since 2016.
Both claims are missing some important fine detail: the medication has been authorised for use in the EU since 2016, but has been newly authorised for a slightly different use in the UK (and many other countries) in 2021. This new authorisation has not yet been granted in the EU.
The claims center around a medication called Osimertinib (brand name Tagrisso). This medication is used in people who have non small cell lung cancer (the most common form of lung cancer) with rare tumours which possess a particular genetic mutation.
The medication has already been licensed in the UK and EU for use in people with mid and later stage non small cell lung cancer.
The new authorisation announced in May, however, allows a new use of the medication in the UK, at an earlier stage in the disease, and is intended to be used to treat patients (who meet certain criteria) with early stage lung cancer after surgery in order to prevent recurrence. This new use has been approved by 15 other countries including the US and China.
The new use has not yet been authorised in the EU. However, It was recommended for approval by the European Medicines Agency (EMA) during a review by the Committee for Medicinal products for Human Use (which is a subgroup of the EMA) in April 2021, but this change has to be approved by the European Commission.
The health secretary Matt Hancock, has said that the speed of the new authorisation in the UK has come about thanks to the UK being able to join ‘Project Orbis’ following opportunities presented post-Brexit.
Project Orbis is a programme which allows the review of medications and products used in cancer treatments by international partner regulatory authorities. This is coordinated by the US Food and Drug Administration and includes nations such as the UK, the US, Canada, Australia, Singapore, Switzerland and Brazil.
The recommendation for authorisation of this new use has already been made by the EMA subgroup, and therefore may be authorised by the EU soon. The EMA told Full Fact that this decision-making process normally takes two months.
It is therefore not yet clear how much more quickly the UK has been able to authorise the new use in comparison to the EU; it may be around two months faster.