A post-surgery treatment for lung cancer will be the first to
receive an authorisation from the Medicines and Healthcare
products Regulatory Agency (MHRA) under Project Orbis - only four
months after the agency joined the scheme in January 2021.
Osimertinib (Tagrisso), a medicine made by AstraZeneca, is a
licensed treatment for patients with mid and later stage
non-small cell lung cancer (NSCLC) who test positive for a
specific gene mutation called EGFR. EGFR mutations occur in
approximately 12%* of lung cancer patients. The licence has now
been extended to include a new population of patients in
early-stage disease. The extended licence offers a novel
treatment option for these patients, after their cancer has been
surgically removed, in an area of significant unmet need.
Project Orbis is an innovative programme coordinated by the US
Food and Drug Administration (FDA) with Canada, Australia,
Switzerland, Singapore, Brazil and the UK as other participants.
The programme has been set up to allow participating partners to
review and approve applications for promising cancer treatments
quickly and efficiently.
Prior to the UK joining, the scheme has already given the green
light to many life-saving treatments for patients suffering from
conditions such as breast cancer, lung cancer, liver cancer,
endometrial cancer, and chronic lymphocytic leukaemia.
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.
Health and Social Care Secretary said:
“It is absolutely vital that NHS patients have access to the most
promising, cutting-edge treatments at quickly as possible.
“Leaving the EU presented us with the opportunity to join Project
Orbis – an international collaboration with the top regulators
around the world - to speed up the time it takes to get these new
medicines to patients.
“I am delighted that today we are able to see the first results
of our involvement in this partnership, with a groundbreaking
drug for lung cancer which will soon benefit hundreds of
patients, and I look forward to seeing what further innovations
it will bring to the table.”
Dr June Raine CBE, Chief Executive, Medicines and
Healthcare products Regulatory Agency said:
“With Project Orbis, we are working to ensure that patients
receive earlier access to promising, life-saving cancer
treatments. We know that the earlier we can treat patients, the
better their outcomes. Through international cooperation,
innovation in regulation, and working with others across the
whole health system, the MHRA is cementing the UK’s global
position at the centre of life sciences and healthcare access.”
Tom Keith-Roach, President, AstraZeneca UK,
said:
“Project Orbis is a powerful example of how collaboration between
regulatory authorities around the world can accelerate the
approval of life-changing treatments and we’re delighted that
osimertinib is the first medicine to undergo this innovative
review process with the MHRA. It’s fantastic news that NHS
patients in England with this specific type of early-stage lung
cancer will have early access to this medicine, which could
significantly improve their chance of disease-free survival. We
will continue our work to secure access for patients in the
devolved nations at the earliest possible opportunity.”
Notes to editors
- 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. The scheme has already given the green light
to many life-saving treatments for patients suffering from
conditions such as breast cancer, lung cancer, liver cancer,
endometrial cancer, and chronic lymphocytic leukaemia.
- The Medicines and Healthcare products Regulatory Agency is
responsible for regulating all medicines and medical devices in
the UK by ensuring they are of good quality, effective and are
acceptably safe. All our work is underpinned by robust and
fact-based judgements to ensure that the benefits justify any
risks.
- The Medicines and Healthcare products Regulatory Agency (‘the
agency’) has three centres. The MHRA Regulatory centre, the
National Institute for
Biological Standards and Control (NIBSC) and the Clinical
Practice Research Datalink (CPRD). The agency is an
executive agency of the Department of Health and Social Care.
-
*Midha A, Dearden S, McCormack R. EGFR mutation
incidence in non-small cell lung cancer of adenocarcinoma
histology: a systematic review and global map by ethnicity
(mutMapII). Am J Cancer Res.
2015;5;2892-2911.
