AstraZeneca lung cancer drug Tagrisso approved by EU regulators

Tagrisso, otherwise known as osimertinib, will now be administered for adults with unresectable, EGFR-mutated non-small cell lung cancer (NSCLC), after reducing the risk of disease progression or death by an unprecedented 84% compared with a placebo in the LAURA trial.

This was the fifth major approval of the drug based on the LAURA trial, following approvals in the US, Switzerland, South Korea and Australia. Regulatory applications are also currently under review in China, Japan and several other countries.

Of the estimated 450,000 people diagnosed with lung cancer in Europe each year, 80-85% have NSCLC, and around 10-15% of those have tumours with an epidermal growth factor receptor (EGFR) mutation.

Manuel Cobo, lead investigator for the trial, hailed the approval as a "major breakthrough" for patients and said the trial "set a new benchmark for outcomes and underscored the importance of testing for EGFR mutations upon diagnosis".

Commenting on the news, AstraZeneca's executive vice president of its oncology business unit, Dave Fredrickson, said: "Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy."