AstraZeneca PLC's (LSE:AZN) Tagrisso has been approved in Europe for treating adults with non-small cell lung cancer (NSCLC) that cannot be removed by surgery.
The approval is for patients whose tumours have an EGFR mutation, a change in their DNA that helps cancer grow.
The decision is based on the results of the LAURA trial, which showed that Tagrisso significantly slowed the progression of cancer.
People taking the drug went over three years without their cancer worsening, compared to just five months for those given a placebo.
This approval is the first in Europe for a medicine targeting unresectable, EGFR-mutated NSCLC.
Experts say it offers new hope to patients who previously had few treatment options.
Tagrisso is already approved in countries such as the US and Australia, and its use is being reviewed in other parts of the world.
Dave Fredrickson, head of AZ's oncology unit said: "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."