AstraZeneca PLC (LON:AZN) said Tagrisso has been approved in the EU for the adjuvant treatment of adult patients with a type of early-stage lung cancer.
It targets epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) which has already tried to be removed surgically.
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The approval by the European Commission was based on positive results from the ADAURA Phase III trial in which Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival.
The candidate reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA of the disease and by 80% in the overall trial population of patients.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease, the FTSE 100 group said.
Historically, nearly half of patients diagnosed in Stage IB, and over three-quarters of patients diagnosed in Stage IIIA, have experienced disease recurrence within five years.
About a fifth of the world's lung cancer patients are in the EU and among those with NSCLC, approximately 15% have tumours with an EGFR mutation.
Tagrisso is now approved to treat early-stage lung cancer in more than fifty countries, including in the US and China, and additional global regulatory reviews are ongoing.
"We know the earlier a patient's cancer is detected and treated, the greater chance they may have of being cured, which is why this approval is significant,” said Dave Fredrickson, executive vice president at the oncology business unit.
“For the first time, patients in the EU with EGFR-mutated lung cancer have a targeted, biomarker-driven treatment option available in the early stages of their disease that can help them live cancer-free longer."