AZ' Tagrisso first to win MHRA approval under Project Orbis

AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.

Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland, Singapore, Brazil and the UK as other participants, which offers a framework for concurrent submissions and collaboration reviews for promising cancer treatments.

Tagrisso is 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, which occur in around 12% of lung cancer patients.

The treatment scope of the drug has now been expanded under Project Orbis to include a new population of patients in early-stage disease, offering a novel treatment option for these patients after their cancer has been surgically removed.

NHS England, NICE and AstraZeneca have reached an agreement to enable early access to the drug for early-stage lung cancer patients in England "on a budget-neutral basis to the NHS while NICE undertakes its appraisal", the MHRA noted.

“With Project Orbis, we are working to ensure that patients receive earlier access to promising, life-saving cancer treatments,” said Dr June Raine CBE, chief executive of the MHRA.

“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.”

“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,” said Tom Keith-Roach, president of AstraZeneca UK.

“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.”