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First authorisation under Project Orbis - UK MHRA

Updated: May 11, 2021

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.

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.

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.

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.

Source Credits: MHRA


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