AstraZeneca PLC on Monday said it has received approval in the European Union for Tagrisso, its non-small cell lung cancer treatment.
The Cambridge-based pharmaceutical company said the approval followed its Laura phase 3 trial, which demonstrated that Tagrisso extended the median progression-free survival for adult patients to more than three years.
It also reduced the risk of disease progression or death by 84% compared to a placebo.
Every year in Europe, more than 450,000 people are diagnosed with lung cancer, of which between 80% to 85% have non-small cell lung cancer. Around 2.4 million people are diagnosed globally.
Executive Vice President of AstraZeneca’s 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 for chemo radiation therapy.
‘The powerful results from the Laura trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer.’
This is the fifth major approval for Tagrisso, following other recent approvals in the US, Switzerland, South Korea and Australia.
Further applications are currently under review in China, Japan and several other countries.
Shares in AstraZeneca were up 1.5% at 10,412.00 pence each in London on Monday morning.
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