UK medicines regulator issues its first authorisation under Project Orbis
UK medicines regulator issues its first authorisation under Project Orbis for Osimertinib (Tagrisso), a post-surgery treatment for lung cancer.
From:
7 May 2021
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
Patterns and bottlenecks
A year into the severe acute respiratory syndrome coronavirus 2 pandemic, we are experiencing waves of new variants emerging. Some of these variants have worrying functional implications, such as increased transmissibility or antibody treatment escape. Lythgoe
et al. have undertaken in-depth sequencing of more than 1000 hospital patients isolates to find out how the virus is mutating within individuals. Overall, there seem to be consistent and reproducible patterns of within-host virus diversity. The authors observed only one or two variants in most samples, but a few carried many variants. Although the evidence indicates strong purifying selection, including in the spike protein responsible for viral entry, the authors also saw evidence for transmission clusters associated with households and other possible superspreader events. After transmission, most variants fizzled out, but occasionally some initiated ongoing transmission and wider dissemination.
The UK has a strong genetics research base: but to date, academics have found it difficult to progress gene therapy research into clinical trials and beyond. The Sheffield Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three new hubs, announced this month, that will tackle these challenges.
The investment in the three ‘cutting-edge hubs’ totals £18m ($24.9m), with the sites dedicated to advancing the clinical development of new genetic treatments.
The Sheffield hub will also include a GMP (good manufacturing practice) facility that will support gene therapy projects emerging from universities across the UK. As well as manufacturing clinical grade adeno-associated viruses (AVV), it will also be ready to investigate ways to ‘radically increase yields and reduce productivity barriers in future years’.
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